MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY M300; PHYSIOLOGICAL MONITORING SYSTEMS

Catalog Number	MS26076
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Codes	Arrhythmia (1721); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Event or Problem Description
It was reported that the draeger infinity m300 failed to alarm during an event.The patient was resuscitated but later died.
Event or Problem Description
It was reported that the draeger infinity m300 failed to alarm during an event.The patient was resuscitated but later died.
Additional Manufacturer Narrative
The dräger service engineer became involved first four days after the event while the concerned central monitoring station (ics) has remained in use.Thus, patient trend information at the ics was already overwritten.The alarm log shows that - prior to the reported time of event - numerous medium-priority alarm were raised indicating that the heart rate was exceeding the adjusted threshold of 140bpm.Starting at 22:09 system time the device detected intermittently a high impedance at the processing electrode leads posted the corresponding "ecg leads off" alarm.The stored data shows that only lead iii was still present continously.The ecg trace ended suddenly at 22:48 system time - most likely the patient was disconnected from the monitoring equipment to perform the resuscitation.The patient monitor m300 could be evaluated on-site.Tests were performed with the device which did not reveal any deviations from specification; provoked alarms were announced as expected.Dräger finally concludes the following: the available information gives no indication for the potential presence of a device malfunction that may have caused or contributed to the worsening of the patient status.There is evidence that physiological alarms were triggered around the time of event and, also the "leads-off" condition was properly announced.The algorithm can be set to arrythmia detection based on one or two leads - the particular processing leads have to be configured in advance.The recorded data indicates that only lead iii was continuously active while for others intermittently a high impedance was detected.It is not exactly known which leads were selected for the particular monitoring episode - however, the device behavior is different for the individual conditions: if the remaining lead (is one of) the pre-selected one(s) the arrythmia detection will basically work and, the central station ics will display a white text-message (in ics bedview only) indicating the specific leads-off condition.If, on the other hand, the electrode(s) that were configured for arrythmia processing had come off or exhibit a too high impedance due to e.G.Aging/dry-out effects the algorithm cannot detect events as intended anymore - the ics will post an audible and visual alarm indicating the leads-off condition to the user.The priority for this type of alarm can be set by the user individually, in the particular case it was defined as "medium-grade".Thus, the facts indicate that the arrythmia detection was significantly impaired due to the fluctuating or increasing impedance of the pre-selected processing lead(s).It is under responsibility of the user to respond in a timely manner also to technical alarms to ensure that monitoring of the individual patient is not interrupted.

• Brand Name: INFINITY M300
• Common Device Name: PHYSIOLOGICAL MONITORING SYSTEMS
• 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 ; 9784470587
• MDR Report Key: 17421588
• Report Number: 1220063-2023-00026
• Device Sequence Number: 18398456
• Product Code: MHX
• UDI-Device Identifier: 04049098002035
• UDI-Public: (01)04049098002035(11)220225(91)VG2.4(93)MS26076-34
• Combination Product (Y/N): N
• PMA/510(K) Number: K151860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MS26076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 07/29/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 119 KG