Tempus LS-MANUAL 3.940589Recalls & reported problems

Summary

The FDA's MAUDE database contains 391 adverse event reports that list this exact device (DI 07613365002737), received between Feb 15, 2021 and Sep 15, 2026 — classified as 34 deaths, 51 injuries, 306 malfunctions.

The most frequently reported specific device problem is “No Pacing” (151 reports).

4 FDA recall records name this device's identifier, 3 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 28, 2024Open, Classified

   Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.

   Z-0557-2025 · Root cause: Labeling Change Control · FDA record ↗

2. May 9, 2024Open, Classified

   Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.

   Z-2028-2024 · Root cause: Labeling design · FDA record ↗

3. May 8, 2023Open, Classified

   Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure DPM".

   Z-1825-2023 · Root cause: Device Design · FDA record ↗

4. Nov 17, 2020Terminated

   A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer back into manual mode the pacer pulse wave may put the ECG calibration out of calibration. This software error may result in a delay in therapy, as the clinician is not provided an ECG waveform on which a shockable rhythm decision can be made. The device is still able to deliver a manual defibrillation shock.

   Z-0564-2021 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 391 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Unable to Obtain Readings

  This report is based on information provided by a Philips Remote Service Engineer, a Bench Engineer and a Technical Engineer and has been investigated by the Philips Complaint Handling Team. Philips received a complaint on the Tempus LS Manual indicating that the not capturing all 3 leads. No patient involvement was reported; therefore, there were no health consequences or impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766698 ↗
• MalfunctionSep 8, 2026Unable to Obtain Readings

  Patient problems: Cardiac Arrest

  MAUDE report 50674003 ↗
• MalfunctionSep 8, 2026Unable to Obtain Readings

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674002 ↗
• MalfunctionAug 6, 2026Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50163483 ↗
• MalfunctionAug 3, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50121970 ↗
• MalfunctionJun 3, 2026Material Integrity Problem

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY A SCHILLER US BENCH ENGINEER AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS MANUAL DEFIBRILLATOR, WHILE AT A BENCH REPAIR FACILITY, INDICATING THAT THE DEVICE LCD (LIQUID CRYSTAL DISPLAY) RIBBON CABLE CONTACTS WERE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25376228 ↗
• MalfunctionJun 3, 2026Break

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY A SCHILLER US BENCH ENGINEER AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS MANUAL DEFIBRILLATOR, WHILE AT A BENCH REPAIR FACILITY, INDICATING THAT THE DEVICE ECG (ELECTROCARDIOGRAPHY) CONNECTOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25375612 ↗
• MalfunctionMay 28, 2026Device Markings/Labelling Problem

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS REMOTE SERVICE ENGINEER AND A BENCH ENGINEER AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS INDICATING THAT THE DEVICE MISSING LOGO STICKER FOUND DURING BENCH REPAIR. THE DEVICE WAS NOT IN USE, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25321718 ↗
• MalfunctionMay 15, 2026Fitting Problem; Wireless Communication Problem

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY REMOTE SERVICE ENGINEER RSE AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS MANUAL DEFIBRILLATOR INDICATING AFTER SERVICE, THE CUSTOMER RECEIVED THE DEVICE BACK AND IS UNABLE TO PAIR TO THE TEMPUS PRO. THERE WAS NO IMPACT TO THE PATIENT, AND THIS REPORTED PROBLEM WAS DISCOVERED IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25187195 ↗
• MalfunctionMay 11, 2026Mechanical Problem

  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 LS MANUAL DEVICE INDICATING THE CABLE CONNECTION BROKE OFF INSIDE THE UNIT. THE DEVICE WAS NOT IN USE DURING THIS EVENT, THEREFORE NO PATIENT OR USER HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142222 ↗
• MalfunctionMay 11, 2026Power Problem

  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 LS MANUAL INDICATING THAT WHILE THE DEVICE WAS REMOVED FROM SERVICE AT THE THIRD-PARTY BENCH REPAIR, AN EMERGENT ISSUE REGARDING THE CENTRAL PROCESSING UNIT (CPU) WAS DISCOVERED. THE CPU WAS CAUSING A CURRENT CONSUMPTION TEST FAILURE. AS THE DEVICE WAS REMOVED FROM SERVICE AT THE TIME OF THE DISCOVERY, NO PATIENT WAS INVOLVED DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25138718 ↗
• MalfunctionApr 17, 2026Electrical /Electronic Property Problem; Protective Measures Problem

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS REMOTE SERVICE ENGINEER AND A BENCH ENGINEER AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS INDICATING THAT THE MEASURE JOULES VALUE IS OUT OF RANGE DURING PREVENTIVE MAINTENANCE. THE DEVICE WAS NOT IN USE, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916050 ↗
• MalfunctionApr 16, 2026Incorrect Measurement; Inappropriate/Inadequate Shock/Stimulation

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY A THIRD PARTY ENGINEER AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS MANUAL INDICATING THAT THE DEVICE MEASURED JOULE VALUE WAS OUT OF RANGE DURING PREVENTATIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24905363 ↗
• MalfunctionApr 7, 2026Defibrillation/Stimulation Problem; Adverse Event Without Identified Device or Use Problem; Key or Button Unresponsive/not Working

  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 LS MANUAL DEFIBRILLATOR INDICATING WHILE RECEIVING PREVENTIVE MAINTENANCE, THE SHOCK BUTTON WILL NOT WORK. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM NOR IMPACT WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801855 ↗
• MalfunctionApr 3, 2026Display or Visual Feedback Problem

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS REMOTE SERVICE ENGINEER AND A BENCH ENGINEER AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS INDICATING THAT THE DEVICE SCREEN HAS LOTS OF DIFFERENT COLOURS AND IS NOT FUNCTIONING PROPERLY. THE DEVICE WAS NOT IN USE, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24782460 ↗
• MalfunctionMar 11, 2026Failure to Discharge

  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 WHILE ON A CALL, THE CREW REPORT THE MONITOR WAS POWERED ON AND CHARGED APPROPRIATELY FOR DEFIBRILLATION. ON MULTIPLE OCCASIONS, AFTER CHARGING TO THE SELECTED ENERGY LEVEL, ACTIVATION OF THE SHOCK BUTTON DID NOT DELIVER A SHOCK. IN AT LEAST ONE INSTANCE, THE CHARGE WAS AUTOMATICALLY CANCELLED WHEN ATTEMPTING TO DELIVER THE SHOCK. AT OTHER TIMES DURING THE SAME RESUSCITATION, THE DEVICE FUNCTIONED NORMALLY AND SUCCESSFULLY DELIVERED DEFIBRILLATION. ADDITIONALLY, THERE WERE EPISODES OF NOTICEABLE DELAY BETWEEN PRESSING THE SHOCK BUTTON AND ENERGY DELIVERY. THE CREW ALSO REPORT THIS MALFUNCTION WAS INTERMITTENT AND INCONSISTENT THROUGHOUT THE EVENT. THERE WAS NO REPORTED IMPACT TO THE PATIENT AT THIS TIME.

  Patient problems: Unspecified Heart Problem

  MAUDE report 24574327 ↗
• MalfunctionMar 10, 2026Battery Problem

  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 LS MANUAL DEFIBRILLATOR INDICATING THAT THE DEVICE HAD A BATTERY ERROR MESSAGE WHEN THE DEVICE WAS TURNED ON BUT THE BATTERY WAS FULLY CHARGED. THERE WAS NO REPORTED PATIENT INVOLVEMENT, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561212 ↗
• MalfunctionFeb 26, 2026Inappropriate Waveform

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY A REMOTE SERVICE ENGINEER AND IS CURRENTLY UNDER INVESTIGATION BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS MANUAL DEFIBRILLATOR INDICATING WHEN PACING, WHILE USING A SIMULATOR AS THE PATIENT, THE RED PACER SPIKES ARE SPORADIC IN THEIR APPEARANCE AND THEN EVENTUALLY DISAPPEAR. THE MONITOR WILL ACTUALLY PACE AS YOU CAN SEE WHEN IT GETS CAPTURE BY THE CHANGING OF THE WIDTH OF THE QRS, HOWEVER THERE IS NO PACER SPIKE PRIOR TO THE QRS AS IT SHOULD BE. THE CUSTOMER IS AN EMS TRAINING FACILITY AND WERE USING IT WITH TRAINING OF PARAMEDIC STUDENTS WITH A SIMULATOR AS THE PATIENT, THERE IS NO PATIENT INVOLVEMENT. THE UNIT DID NOT ACT AS IF ANYTHING WAS WRONG. AFTER A LONG SHUT DOWN IT WAS TURNED BACK ON AND RETURNED TO NORMAL PRESENTATION OF PACER SPIKES THEN LOSES THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456829 ↗
• MalfunctionJan 30, 2026Failure to Calibrate; Battery Problem

  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 LS MANUAL INDICATING THAT THE DEVICE HAD A BATTERY FAILURE ERROR MESSAGE AND WOULD NOT PASS THE SELF TEST. THERE WAS NO REPORTED PATIENT INVOLVEMENT, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219914 ↗
• MalfunctionJan 16, 2026Unable to Obtain Readings

  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 LS MANUAL INDICATING WHILE ON A CALL WITH A PATIENT IN CARDIAC ARREST, THREE DIFFERENT SETS OF THE PADS SAID TO CONNECT DEFIB PAD WHEN THEY WERE ALREADY CONNECTED TO THE DEVICE. THERE WAS NO REPORT OF HARM.

  Patient problems: Cardiac Arrest

  MAUDE report 24099854 ↗
• MalfunctionJan 16, 2026Unable to Obtain Readings

  This report is based on information provided by Remote Service Engineer RSE, Third-Party Repair Technician and has been investigated by the Philips Complaint Handling Team. Philips received a complaint on the Tempus LS Manual defibrillator indicating that while on a cardiac arrest, the device read error " Check Electrodes", although electrodes were attached. There was no impact to the patient.

  Patient problems: Cardiac Arrest

  MAUDE report 24097849 ↗
• MalfunctionJan 2, 2026Unable to Obtain Readings

  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 LS MANUAL DEFIBRILLATOR INDICATING DURING AN EMERGENCY CALL ON(B)(6) 2025, THE CREW CONNECTED THE DEFIBRILLATOR TO THE PATIENT WITH NO HEART RHYTHM SHOWN AND MESSAGE ONSCREEN "CHECK ELECTRODES". THE CREW MEMBER CONFIRMED GOOD PLACEMENT ON PATIENT AND CONNECTION, BUT NO CHANGE WITH THE TEMPUS LS. A SECOND SET OF PADS WERE ALSO ATTEMPTED TO OBTAIN A 4-LEAD ECG (ELECTROCARDIOGRAM), HOWEVER THE DEVICE HAD THE SAME ERROR "CHECK ELECTRODES". A THIRD SET OF PADS WERE USED AND MONITOR STILL DISPLAYED ERROR "CHECK ELECTRODES". THE CREW REPORTED THE PATIENT STARTED IN AND MAINTAINED ASYSTOLE (FLATLINE) AND PEA (PULSELESS ELECTRICAL ACTIVITY) THROUGHOUT THE CARDIAC ARREST.

  Patient problems: Cardiac Arrest

  MAUDE report 23945662 ↗
• MalfunctionDec 22, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

  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 LS, INDICATING THE DEVICE WILL NOT PASS SELF TEST. THE DEVICE WAS NOT IN CLINICAL USE; NO PATIENT OR USER WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872573 ↗
• MalfunctionNov 5, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT IS BASED ON INFORMATION PROVIDED BY THE REMOTE SERVICE ENGINEER RSE AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ABOUT THE TEMPUS LS MANUAL, STATING THAT THE CPR SENSOR (CARDIOPULMONARY RESUSCITATION) ACCESSORIES ARE NOT PROVIDING ACCURATE FEEDBACK.

  Patient problems: Insufficient Information

  MAUDE report 23474741 ↗
• MalfunctionNov 4, 2025Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  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 LS MANUAL INDICATING THAT THE DEVICE WAS NOT FUNCTIONING, SCREEN FLICKERING AND REBOOTED. THERE WAS NO REPORTED PATIENT INVOLVEMENT, THEREFORE NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468040 ↗