Delta Monitor MS18597Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04049098004152), received between Apr 6, 2022 and Nov 26, 2024 — classified as 2 deaths, 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K070566); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• DeathNov 26, 2024No Audible Alarm; No Audible Alarm

  THE CUSTOMER ALLEGED THAT THE DELTA DID NOT TRANSMIT OR RECORD ALARMS FOR THREE HOURS, DURING WHICH THE PATIENT NEEDED RESUSCITATION THAT DID NOT RECEIVE. REPORTEDLY, THE PATIENT PASSED AWAY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20778239 ↗
• MalfunctionMay 14, 2024Sparking; Sparking

  THE CUSTOMER REPORTED THAT THE DELTA POWER SUPPLY UNIT CAUGHT FIRE WHEN PLUGGED INTO THE MAIN POWER SUPPLY. THE POWER SUPPLY UNIT AND DOCKING STATION WERE MOUNTED ON A TROLLEY, WITH THE MAINS PLUG FACING UPWARDS. THE TRANSPORT TROLLEY WAS CONNECTED TO A PATIENT AT THE TIME OF THE INCIDENT, AND THE DELTA WAS CONNECTED TO THE POWER SUPPLY TO BRIDGE A WAITING PERIOD. THE PLUG OF THE POWER SUPPLY UNIT WAS CONNECTED TO A MULTIPLE SOCKET ON THE TROLLEY, AND THERE WAS A BANG AND A "JET OF FLAME" IN THE AREA OF THE POWER SUPPLY UNIT. NO PATIENT OR USER INJURY OR DEATH WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19311689 ↗
• InjuryMay 14, 2024Unintended Electrical Shock; Unintended Electrical Shock

  THE CUSTOMER REPORTED A POWER FAILURE IN A WARD AND THAT A DELTA MONITOR WAS NO LONGER STARTING UP. THE MONITOR WAS ALSO NOT IN OPERATION AND NO PATIENT OR EMPLOYEE HAD BEEN IN CONTACT WITH IT. ON MAY 03 2024, A UFR WAS RECEIVED STATING THAT AN EMPLOYEE HAD BEEN SHOCKED WHEN PLACING THE DELTA ON THE DOCKING STATION, TRIGGERING THE STATION'S CIRCUIT BREAKER. NO DETAILS REGARDING THE ELECTRIC SHOCK WERE PROVIDED, AND NO REPORT OF PATIENT DEATH WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310617 ↗
• MalfunctionApr 19, 2024Inaudible or Unclear Audible Prompt/Feedback; Inaudible or Unclear Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT THERE WAS NO ALARM HEARD FOR AN ASYSTOLE ON A DELTA DEVICE. NO ADDITIONAL INFORMATION REGARDING THE EVENT WAS PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY OR DEATH.

  Patient problems: Asystole

  MAUDE report 19144921 ↗
• MalfunctionMar 18, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT, DURING PATIENT MONITORING, THE DELTA DID NOT ALARM DURING A PATIENT'S DESATURATION. THE REPORTED EVENT OCCURRED IN AN ICU ON FEB 12, AT 1400. THERE IS NO INFORMATION STATING THERE IS ANY ADVERSE PATIENT IMPACT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18921326 ↗
• MalfunctionJan 10, 2024Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT CUSTOMER IS REQUESTING A DISPATCH ON THEIR DELTA SINCE THE SCREEN WENT BLACK IN THE MIDDLE OF A CASE AND THEY WERE NOT ABLE TO GET IT BACK ON UNTIL THIS MORNING. NO PATIENT INJURY. THE MONITOR WAS SWITCHED OUT DURING CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18487555 ↗
• MalfunctionDec 27, 2023No Device Output; Failure to Sense; No Device Output; Failure to Sense

  IT WAS REPORTED THAT THE PATIENT MONITOR LOST THE CO2 TRACE DURING AN ANESTHETIC PROCEDURE AND WAS ALARMING FOR BATTERY ERROR. THE DELTA PATIENT MONITOR WAS CONNECTED VIA AN INFINITY DOCKING STATION (IDS) TO A DRÄGER FABIUS ANESTHESIA WORKSTATION; THE GAS READINGS WERE PROVIDED BY A DRÄGER SCIO ANESTHETIC GAS MONITOR. IT WAS MENTIONED IN THE REPORT THAT THE EVENT DID NOT LEAD TO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18401266 ↗
• MalfunctionOct 20, 2023Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO DRÄGER THAT DEVICE REBOOTS OCCUR RANDOMLY FOR NO OBVIOUS REASON AND THAT THIS AFFECTS MORE THAN ONE DEVICE. PATIENT MONITORING WAS ALWAYS CONTINUED AFTER THE REBOOT. IT WAS CONFIRMED TO DRÄGER THAT THE REPORTED ISSUE DID NOT LEAD TO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17973486 ↗
• InjuryJul 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE OPERATOR GRABBED THE MONITOR BY THE HANDLE FOR MOVING THE PATIENT FROM THE INDUCTION ROOM TO THE OPERATING ROOM. DURING THE OPERATION THE CASING BROKE AND THE HANDLE CAME OFF THE MONITOR THAT FELL ON THE OPERATOR'S FOOT. AFTER THE EMERGENCY ROOM VISIT, WHERE NO FRACTURES WERE FOUND, THE OPERATOR HAD A FEW DAYS OF SICKNESS. NO SPECIFIC DETAILS REGARDING ANY MEDICAL INTERVENTION/TREATMENT THAT MAY HAVE BEEN RECEIVED AT THE ER WAS PROVIDED.

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

  MAUDE report 17406132 ↗
• DeathJun 9, 2023No Audible Alarm; No Audible Alarm

  ON 1JUN2023 IT WAS REPORTED TO A DRÄGER TECHNICIAN THAT AN EVENT OCCURRED WITH A DRÄGER INFINITY DELTA PATIENT MONITOR MOUNTED TO A DRÄGER PRIMUS ANESTHESIA WORKSTATION WHERE IT WAS REPORTED THAT THE MONITOR DID NOT ALARM AND THE INVOLVED PATIENT DIED. THE CUSTOMER IS NOT PROVIDING FURTHER INFORMATION UNTIL THEIR INTERNAL INVESTIGATION IS COMPLETED. ON 5JUN2023 DRÄGER RECEIVED A USER FACILITY REPORT REGARDING THE EVENT IN WHICH VENTILATION PROBLEMS DURING A SURGERY PERFORMED WITH A COMBINATION OF A DRÄGER PRIMUS ANESTHESIA WORKSTATION AND A DRÄGER DELTA PATIENT MONITORING SYSTEM WERE MENTIONED. AS FURTHER INFORMATION IS NOT CURRENTLY AVAILABLE, WE ARE CONSIDERING THE ALLEGATION TO BE AGAINST BOTH THE PRIMUS AND THE DELTA. REMARK: SINCE THE PRODUCT RESPONSIBILITY FOR THE USED DEVICES IS WITH TWO DIFFERENT MANUFACTURING SITES IN THE DRÄGER ORGANIZATION, TWO FILES FOR THE DOCUMENTATION OF INVESTIGATION HAVE BEEN OPENED: INTERNAL REFERENCE # (B)(4) (MDR 9611500-2023-00213) FOR THE PRIMUS ANESTHESIA WORKSTATION AND # (B)(4) (MDR 1220063-2023-00018) FOR THE DELTA PATIENT MONITORING SYSTEM.

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

  MAUDE report 17098795 ↗
• MalfunctionApr 6, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THAT THE UNIT WAS NOT ALARMING DURING VFIB (VENTRICULAR FIBRILLATION). NO ADVERSE PATIENT IMPACT WAS REPORTED. THE HOSPITAL BIOMED WAS UNABLE TO DUPLICATE THE REPORTED MALFUNCTION UPON INITIAL TESTING. THE DEVICE WAS RETURNED TO DRAEGER FOR EVALUATION. IT WAS ADDITIONALLY NOTED THAT THE DEVICE CHASSIS WAS DAMAGED. THE BIOMED STATED NO FURTHER INFORMATION WAS AVAILABLE REGARDING THE EVENT. NOTE THAT THE INITIAL SERVICE REQUEST REPORTED A "CASE CRACKED - NOT ALARMING DURING DFIB". DURING FURTHER REVIEW OF THE SERVICE ORDER, ADDITIONAL INFORMATION WAS REQUESTED FOR SYMPTOM CLARIFICATION AND THE ABOVE INFORMATION WAS RECEIVED ON 10MAR2022 FROM THE HOSPITAL BIOMED CLARIFYING THAT THE DEVICE FAILED TO ALARM FOR VFIB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14032059 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070566. One submission often covers many models, so check the product and lot details in each record.

• Z-0281-2012 · Oct 31, 2011 · Terminated
  Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, physiologically, the vital signs of patients (with Arrhythmia Detection or Alarms).
• Z-3048-2011 · Jul 29, 2011 · Terminated
  Infinity Gamma X XL Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside a
• Z-3047-2011 · Jul 29, 2011 · Terminated
  Infinity Delta Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and tr
• Z-2283-2010 · Jun 4, 2010 · Terminated
  Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.
• Z-2284-2010 · Jun 4, 2010 · Terminated
  Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.
• Z-0582-2010 · Nov 9, 2009 · Terminated
  Delta/Delta XL Monitors with Omega S Package