Tempus Pro 00-1026-R (UDI 05060472441058)Recalls & reported problems

Summary

The FDA's MAUDE database contains 324 adverse event reports that list this exact device (DI 05060472441058), received between Nov 8, 2022 and Sep 29, 2026 — classified as 1 death, 3 injuries, 320 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (39 reports).

7 FDA recall records name this device's identifier, 7 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Nov 26, 2025Class IIOpen, Classified

   Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.

   Z-1027-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. May 30, 2025Class IIOpen, Classified

   Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy and all other monitor measurements during system restart.

   Z-2175-2025 · Root cause: Software change control · Recall details · FDA record ↗

3. Apr 16, 2025Class IIOpen, Classified

   software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.

   Z-1666-2025 · Root cause: Device Design · Recall details · FDA record ↗

4. Apr 15, 2025Class IIOpen, Classified

   Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot after intermittent connection with Smart Mount, 4) 12-lead ECG measurements with Louvain algorithm and software before vx.36 could produce inaccurate rhythm/morphology statements.

   Z-1729-2025 · Root cause: Software design · Recall details · FDA record ↗

5. Aug 24, 2023Class IIOpen, Classified

   Full screen error message may occur on patient monitors with affected hardware version, either during or after laryngoscopes are unplugged from monitors, informing users a 60-100 second shutdown/restart are required. Error prevents: viewing graphical patient vital signs, sounding of pulse audio tone, visualization of patient airway used during intubation; may lead to treatment delay or hypoxia.

   Z-2625-2023 · Root cause: Device Design · Recall details · FDA record ↗

6. Feb 23, 2023Class IIOpen, Classified

   During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.

   Z-1321-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

7. May 25, 2021Class IIOpen, Classified

   The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.

   Z-1997-2021 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 324 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Erratic or Intermittent Display; Imprecision

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937438 ↗
• MalfunctionJun 3, 2026Unexpected Shutdown; Unintended Application Program Shut Down

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT DURING A MEDICAL INTERVENTION OF A PATIENT AFTER RECORDING AND SENDING ELECTROCARDIOGRAM (ECG) READINGS, THE SCREEN FROZE AND THE MONITOR UNEXPECTED RESTARTED. A REQUEST FOR ADDITIONAL INFORMATION REGARDING THE INCIDENT HAS BEEN SENT AND THE RESPONSE IS NOT YET RECEIVED. THERE WAS NO REPORT OF ACTUAL HARM REPORTED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385480 ↗
• MalfunctionJun 3, 2026Unable to Obtain Readings

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT DURING A MEDICAL INTERVENTION THE DEVICE DOES NOT READ 3-LEAD OF 12-LEAD ELECTROCARDIOGRAM (ECG) CABLE. A REQUEST FOR ADDITIONAL INFORMATION REGARDING THE INCIDENT HAS BEEN SENT AND THE RESPONSE IS NOT YET RECEIVED. THERE WAS NO REPORT OF ACTUAL HARM REPORTED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385478 ↗
• MalfunctionJun 3, 2026Key or Button Unresponsive/not Working

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT DURING A MEDICAL INTERVENTION THE DEVICE DID WOULD NOT POWER ON USING THE ON/OFF BUTTON. A REQUEST FOR ADDITIONAL INFORMATION REGARDING THE INCIDENT HAS BEEN SENT AND THE RESPONSE IS NOT YET RECEIVED. THERE WAS NO REPORT OF ACTUAL HARM REPORTED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385133 ↗
• MalfunctionApr 20, 2026Loose or Intermittent Connection; Power Problem

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING AN ISSUE WITH THE DIRECT CURRENT (DC) CONNECTOR. A REQUEST FOR ADDITIONAL INFORMATION REGARDING THE INCIDENT HAS BEEN SENT AND THE RESPONSE IS NOT YET RECEIVED. THERE WAS NO REPORT OF ACTUAL HARM REPORTED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933022 ↗
• MalfunctionApr 16, 2026Operating System Becomes Nonfunctional

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT WHEN POWERING ON THE DEVICE A "ERROR-CRC" (CYCLIC REDUNDANCY CHECK ERROR) OCCURRED. THE DEVICE WAS RESTARTED, BUT THE ERROR CONTINUED. FOLLOWING SUCCESSFUL REINSTALLATION OF THE SOFTWARE THE DEVICE RESTARTED AS EXPECTED, HOWEVER THE ERROR REMAINED. INFORMATION OBTAINED THROUGH GOOD FAITH EFFORT RESPONSE INDICATED THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE INCIDENT. THE INCIDENT OCCURRED DURING A MILITARY EXERCISE. NO HARM OR IMPACT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901249 ↗
• MalfunctionApr 13, 2026Unexpected Shutdown

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT DURING A MEDICAL TRANSPORT OF A VENTILATED PATIENT WITH CIRCULATORY INSTABILITY RECEIVING NOREPINEPHRINE SUPPORT THE TEMPUS PRO MONITOR EMITTED AN AUDIBLE ALERT FOLLOWING BY AN UNEXPECTED RESTART. A REQUEST FOR ADDITIONAL INFORMATION REGARDING THE INCIDENT HAS BEEN SENT AND THE RESPONSE IS NOT YET RECEIVED. THERE WAS NO REPORT OF ACTUAL HARM REPORTED WITH THIS COMPLAINT.

  Patient problems: Hemodynamic instability; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865790 ↗
• MalfunctionJan 9, 2026Wireless Communication Problem

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT DURING A MEDICAL INTERVENTION WHEN STARTING CORSIUM, THE INDICATOR LIGHT DOES NOT STAY SOLID GREEN AND FLASHES. THERE IS NO STABLE CONNECTION. IT WAS OBSERVED WITHIN THE PHYSICIAN'S TOUGHBOOK, THAT THE TEMPUS PRO MONITOR APPEARS, BUT NEITHER LIVE TRANSMISSION NOR ELECTROCARDIOGRAM (ECG) ARE VISIBLE. IT IS NOTED THAT THE MONITOR HAS TO BE REPEATEDLY TURNED OFF AND ON AGAIN BY THE USER. RESPONSE TO GOOD FAITH EFFORT INDICATED LIVE TRANSMISSION AND ECG WERE VISIBLE ON THE TEMPUS PRO DEVICE AND THAT THE ISSUE APPEARED TO BE WITH THE CONNECTION TO CORSIUM. FURTHER INFORMATION PROVIDED INDICATED THE USER ATTEMPTED TROUBLESHOOTING UPON RETURNING TO BASE WITH THE DEVICE INVOLVED IN THE INCIDENT AND ALSO A SECOND DEVICE. THE SECOND DEVICE WAS ABLE TO CONNECT TO CORSIUM WITH NO ISSUES, HOWEVER THE DEVICE INVOLVED IN THE INCIDENT WAS UNABLE TO. THERE WAS NO PATIENT OR USER HARM OR IMPACT AS A RESULT OF THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24027927 ↗
• MalfunctionJan 8, 2026Unable to Obtain Readings

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT DURING A MEDICAL INTERVENTION WHEN ATTEMPTING TO RECORD 12-LEAD ELECTROCARDIOGRAM (ECG), NO ECG WAVEFORM APPEARED ON THE MONITOR FOR ANY LEAD. THE USER CHECKED AND REAPPLIED THE ECG LEADS SEVERAL TIMES, HOWEVER THE ISSUE PERSISTED. RESPONSE TO GOOD FAITH EFFORT INDICATED THE ECG WAVEFORM WAS SUCCESSFULLY RECORDED USING A SECOND TEMPUS PRO DEVICE THAT WAS USED FROM THE DOCTOR'S CAR WHICH WAS ALSO ONSITE WITH THE SAME PATIENT. NO PATIENT OR USER HARM WAS CONFIRMED AS A RESULT OF THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24010352 ↗
• MalfunctionDec 31, 2025Fitting Problem; Communication or Transmission Problem; Fitting Problem; Communication or Transmission Problem

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT DURING A MEDICAL INTERVENTION WHEN DEFIBRILLATOR ELECTRODES WERE ATTACHED TO THE DEFIBRILLATOR, THE DEFIBRILLATOR DID NOT PAIR WITH THE MONITOR AND PRINTING OF THE ELECTROCARDIOGRAM (ECG) WAS NOT POSSIBLE. INFORMATION OBTAINED VIA GOOD FAITH EFFORT INDICATED THE PATIENT WAS DECEASED PRIOR TO THE DEPLOYMENT OF THE DEVICE. AS THE EVENT OCCURRED, POST-MORTEM, THE REPORTED ISSUE DID NOT CAUSE OR CONTRIBUTE TO PATIENT HARM OR DEATH. ANALYSIS OF THE INCIDENT LOG FILES ARE PENDING AT THIS TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934945 ↗
• MalfunctionDec 12, 2025Erratic or Intermittent Display; Unable to Obtain Readings; Erratic or Intermittent Display; Unable to Obtain Readings

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT WHEN THE USER ATTEMPTED TO SET TOUCHSCREEN FOR ACTIVATING PRINTING OR SENDING ELECTROCARDIOGRAM (ECG), THE TOUCHSCREEN QUICKLY REVERTED TO THE DEFAULT DISPLAY. THE USER INDICATED THIS OCCURRED REPEATEDLY. NO HARM OCCURRED TO THE PATIENT. RESPONSE TO GOOD FAITH EFFORT INDICATED THE ECG WAS SUCCESSFULLY MEASURED DURING THE INCIDENT. ECG RECORDING WAS THEN SUCCESSFULLY SENT TO CLINICAL VIA EMAIL. LOG FILES WERE PROVIDED FOR FURTHER ANALYSIS. FINAL INVESTIGATION RESULTS ARE PENDING COMPLETED INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23795271 ↗
• MalfunctionNov 24, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT WHEN ATTEMPTING TO MONITOR THE PATIENT, THE TOUCHSCREEN DOES NOT RESPOND TO ANY TOUCHSCREEN BUTTONS. THE USER INDICATED THEY PERFORMED A HARD RESTART OF THE MONITOR BY PRESSING THE ON/OFF BUTTON. RESPONSE TO GOOD FAITH EFFORT ATTEMPT INDICATED CONFIRMED THERE WAS NO ACTUAL HARM TO THE PATIENT AND NO DELAY TO THERAPY OCCURRED AT THE TIME OF THE INCIDENT. PATIENT FULL DISCLOSURE REPORT AND LOG FILES HAVE BEEN RECEIVED AND ARE PENDING ANALYSIS. AN ADDITIONAL REQUEST FOR INFORMATION HAS BEEN SENT AND THE RESPONSE IS NOT YET RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638095 ↗
• MalfunctionOct 30, 2025Computer Operating System Problem; Computer Operating System Problem

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY REMOTE SERVICE ENGINEER RSE, PRODUCT SUPPORT ENGINEER, AND SERVICE ENGINEER AND IS CURRENTLY UNDER INVESTIGATION BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO, INDICATING THAT THE DEVICE CAN NOT BOOT UP. IT SHOWS CANNOT LOCATE MPM APPLICATION.EXE. THE DEVICE USE DURING THE TIME OF THE EVENT IS UNKNOWN; HOWEVER, NO PATIENT OR USER HEALTH WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425633 ↗
• MalfunctionJul 28, 2025Crack; Crack

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY REMOTE SERVICE ENGINEER RSE AND IS CURRENTLY UNDER INVESTIGATION BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THE SCREEN IS CRACKED. IT IS UNKNOWN AT THIS TIME IF THERE WAS PATIENT INVOLVEMENT, HOWEVER, GOOD FAITH ATTEMPTS HAVE BEEN INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636651 ↗
• MalfunctionJul 9, 2025Break; Break

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY REMOTE SERVICE ENGINEER RSE, PRODUCT SUPPORT ENGINEER, SERVICE ENGINEER AND IS CURRENTLY UNDER INVESTIGATION BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THE DC (DIRECT CURRENT) CHARGING PORT HAS A BROKEN PIN. NO PATIENT INVOLVEMENT AS THIS REPORTED PROBLEM OCCURRED WHILE AT THE BENCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22462440 ↗
• MalfunctionJul 9, 2025Crack; Crack

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY REMOTE SERVICE ENGINEER RSE, PRODUCT SUPPORT ENGINEER, SERVICE ENGINEER AND IS CURRENTLY UNDER INVESTIGATION BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING WHILE AT THE BENCH, THE FRONT CASE ENCLOSURE WAS DISCOVERED TO BE CRACKED NEAR THE BATTERY COMPARTMENT. NO PATIENT INVOLVEMENT, NO IMPACT ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461633 ↗
• MalfunctionJul 1, 2025Material Integrity Problem; Material Integrity Problem

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY SERVICE ENGINEER AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THE DC (DIRECT CURRENT) CONNECTOR IS EXTREMELY LOOSE. THERE WAS NO PATIENT INVOLVEMENT AND NO IMPACT ALLEGED AS THIS WAS A BENCH FINDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372903 ↗
• MalfunctionJul 1, 2025Material Integrity Problem; Material Integrity Problem

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY SERVICE ENGINEER AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THE ECG (ELECTROCARDIOGRAM) CONNECTOR IS LOOSE. THERE WAS NO PATIENT INVOLVEMENT AND NO IMPACT ALLEGED AS THIS WAS A BENCH FINDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372895 ↗
• MalfunctionJun 27, 2025Poor Quality Image; Poor Quality Image

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS FIELD SERVICE ENGINEER, BENCH ENGINEER AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE CAMERA IS ONLY DISPLAYING A GREEN DURING TESTING. THE DEVICE WAS OUTSIDE OF CLINICAL USE; THEREFORE NO PATIENT OR USER HARM. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22349439 ↗
• MalfunctionJun 27, 2025Unexpected Shutdown; Unexpected Shutdown

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY REMOTE SERVICE ENGINEER RSE AND IS CURRENTLY UNDER INVESTIGATION BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THE DEVICE IS NOT STARTING UP CORRECTLY SOMETIMES DURING TESTING. THE DEVICE WAS NOT IN USE AT THE TIME OF THE PAIRING, AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22349402 ↗
• MalfunctionJun 27, 2025Break; Break

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS REMOTE SERVICE ENGINEER AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT PART OF THE DEVICE CAPNOGRAPHY WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344750 ↗
• MalfunctionJun 16, 2025No Display/Image; No Display/Image

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY FIELD SERVICE ENGINEER FSE AND IS CURRENTLY UNDER INVESTIGATION BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THE DEVICE HAD NO DISPLAY. NO HARM NOR IMPACT WAS ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213467 ↗
• MalfunctionJun 9, 2025Crack; Crack

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT TOUCHSCREEN HAD "LOOSE FOIL". THERE WAS NO PATIENT INVOLVEMENT REPORTED AT THE TIME OF THE EVENT. THE DEVICE IS BEING HELD IN STORAGE UNTIL A REPAIR CAN BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169814 ↗
• MalfunctionJun 3, 2025Break; Break

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT DURING BENCH ANALYSIS OF THE DEVICE, AN EMERGENT ISSUE OF DAMAGE TO THE CENTER PIN OF THE CHARGING PORT WAS DISCOVERED. AS THE DEVICE WAS AT A THIRD-PARTY BENCH REPAIR FACILITY AT THE TIME OF DISCOVERY, THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT, THEREFORE NO PATIENT OR USER HEALTH CONSEQUENCES OR IMPACT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22135350 ↗
• MalfunctionMay 15, 2025Unexpected Shutdown; Unexpected Shutdown

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY REMOTE SERVICE ENGINEER RSE AND IS CURRENTLY UNDER INVESTIGATION BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THE DEVICE SHUT DOWN DURING PATIENT CARE. THE DEVICE DID REBOOT AND MONITORING WAS COMPLETED. NO IMPACT TO PATIENT WAS ALLEGED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031207 ↗