MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT

Model Number MS20401

Device Problems No Audible Prompt/Feedback (2282); Application Program Problem (2880)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/04/2023

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted upon completion of this investigation.

Event Description

It was reported that during an event where the involved patient almost died, the device failed to provide an alarm.The nurse ward manager reported that the patient was transferred from late to night shift with good saturation values.The late shift had correctly switched on saturation alarm and also checked it.Whether this was also done by the night shift is currently still being clarified.The early shift took over the patient the next morning with a saturation of 76% and poor general condition.Vital signs o.K., therefore no alarm signal of the other parameters.Presumably over hours with poor saturation values without the saturation alarm being triggered.No relevant medication received.The infinity acute care system (iacs) includes an infinity medical cockpit paired with an infinity m540 bedside monitor.Involved infinity m540, ms20401, serial number (b)(6).

Event Description

See initial mfr.Report #.

Manufacturer Narrative

A log file was provided which has been evaluated.The reported condition cannot be confirmed - the spo2 alarm was continuously enabled during the concerned period, multiple instances of active spo2 alarms were logged and, there's also evidence for user interaction with the device - the user has acknowledged spo2 alarms (alarm silence).Indications for the potential presence of a device malfunction were not found.The user facility has reported three similar events to dräger.Within the evaluation of the first complaint, the reported issue could be confirmed: a patient monitor m540 at which the spo2 alarm was disabled during the previous monitoring episode had been docked to the c500 cockpit of another bed place, the standard profile from the cockpit should have been restored to the newly introduced m540.The patient profile has spo2 alarm enabled by default but it was not restored to the m540, the spo2 alarm remained disabled.This was associated to a corrupt profile.It was thus recommended as a result of pr127960 to re-load new profiles to each device in this care unit.The dräger s&s organization had soon started with this activity but this was not yet completed when the second and third instances of this phenomenon were observed by the user.As a consequence, the entire fleet has been uploaded with new profiles again to exclude that one device may not have been included in the measure and continues to spread the failure.The error condition has not recurred since then.Dräger has provided extensive testing of the conditions in the lab but was not able to duplicate the phenomenon and, it was also not observed at any other site so far.The aspect that the evaluated log file was not containing the same signature like the first one may be explained by the fact that the user wasn't 100% sure which device exhibited the issue the second time - there is a lot of "travelling" of the m540 monitors between the bed places in this ward.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Type of Device: PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 9783798000
• MDR Report Key: 17560683
• MDR Text Key: 321308637
• Report Number: 1220063-2023-00027
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K113798
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MS20401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening