MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC M300; PHYSIOLOGIC MONITORING SYSTEM

Catalog Number	MS25755
Medical Device Problem Codes	No Audible Prompt/Feedback (2282); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	12/18/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
The evaluation has just started; results will be provided in a follow-up report.H3 other text : ongoing.
Event or Problem Description
It was reported that a patient was monitored with a telemetry device; the heart rate displayed at the central monitoring station (cms) was 86bpm.A nurse was with the patient until 9:10 pm.The patient had a heart attack within the next few minutes; the bed neighbor called the nurse at 9:14.Unfortunately, the initiated resuscitation efforts were not successful, the patient died.
Additional Manufacturer Narrative
The reported description was clarified: a patient was connected to an infinity m300 telemetry device and according to the display in the associated infinity central station (ics), the ecg showed a heart rate of 86 beats per minute.The nurse looked after the patient until 9:10 pm.Between 9:10 pm and 9:14 pm., the patient suffered a heart attack, and no alarm was provided.A bed neighbor noticed this and immediately informed the nurse.A resuscitation call was made at 9:14 pm, but despite all efforts, the patient died.However, due to a database error in the ics, no long-term data can be retrieved.A draeger field service engineer evaluated the involved m300 and ics, no malfunctions were identified.The m300 and ics logs were provided.It was noted there was a site network issue identified where the wireless access point was incorrectly configured, and the channel setting was not correct.However, based on the ics and m300 logs, there was no indication the m300, or ics was offline during the reported event.The m300 alarm history log show the following alarms were provided between 9 and 9:22pm: 3 ecg artifact alarms (21:00:32, 21:21:09 & 21:21:42), 2 ecg electrodes off alarms (21:16:15 & 21:22:04) and 2 hf > 120 alarms (21:20:56 & 21:21:19).The ics alarm history log show these alarms were also provided at the ics.The ics clinical logs show user-initiated audio pause was selected at the ics at 21:00:09, 21:00:47, 21:01:31, 21:01:36, 21:14:13, 21:14:18, 21:15:18, 21:15:23, 21:16:00, 21:16:29, 21:21:03, 21:21:30 confirming user interaction at the ics during the time of the event.Note that ecg and arrhythmia monitoring cannot be performed when the ecg signal is poor (ecg artifact) or if the leads are disconnected (electrodes off) and therefore, no arrhythmia alarms would be provided until the technical issue is resolved.There was no device malfunction, the expected alarms were provided at the m300 and ics during the event.
Event or Problem Description
It was reported that a patient was monitored with a telemetry device; the heart rate displayed at the central monitoring station (cms) was 86bpm.A nurse was with the patient until 9:10 pm.The patient had a heart attack within the next few minutes; the bed neighbor called the nurse at 9:14.Unfortunately, the initiated resuscitation efforts were not successful, the patient died.
Additional Manufacturer Narrative
Update: further information was received on 24oct2024 noting that a temporary data base issue of the ics was present during the period in question which had the net effect that no long-term data such as ecg long full disclosure or ecg strips covering the whole period could be retrieved.Additionally, the deceased patient was 90 years old and the death was attributed to clinical aspects.The only uncertainty was in regard to the alarm behavior of the devices in use which could be clarified within the course of the investigation: the device issued a technical alarm at 21:00:32 to announce a bad ecg signal quality and that this alarm was noticed by the user.If such condition occurs, arrhythmia detection can be significantly impaired; the ifu emphasizes that it is under responsibility and control of the user to respond also to technical alarms in appropriate manner to ensure continuous monitoring of the individual patient.Therefore, it was concluded that there was no draeger device malfunction that caused or contributed to the patient death and that the devices behaved as specified in the particular situation.From previous submission: the reported description was clarified: a patient was connected to an infinity m300 telemetry device and according to the display in the associated infinity central station (ics), the ecg showed a heart rate of 86 beats per minute.The nurse looked after the patient until 9:10 pm.Between 9:10 pm and 9:14 pm., the patient suffered a heart attack, and no alarm was provided.A bed neighbor noticed this and immediately informed the nurse.A resuscitation call was made at 9:14 pm, but despite all efforts, the patient died.However, due to a database error in the ics, no long-term data can be retrieved.A draeger field service engineer evaluated the involved m300 and ics, no malfunctions were identified.The m300 and ics logs were provided.It was noted there was a site network issue identified where the wireless access point was incorrectly configured, and the channel setting was not correct.However, based on the ics and m300 logs, there was no indication the m300, or ics was offline during the reported event.The m300 alarm history log show the following alarms were provided between 9 and 9:22pm: 3 ecg artifact alarms (21:00:32, 21:21:09 & 21:21:42), 2 ecg electrodes off alarms (21:16:15 & 21:22:04) and 2 hf > 120 alarms (21:20:56 & 21:21:19).The ics alarm history log show these alarms were also provided at the ics.The ics clinical logs show user-initiated audio pause was selected at the ics at 21:00:09, 21:00:47, 21:01:31, 21:01:36, 21:14:13, 21:14:18, 21:15:18, 21:15:23, 21:16:00, 21:16:29, 21:21:03, 21:21:30 confirming user interaction at the ics during the time of the event.Note that ecg and arrhythmia monitoring cannot be performed when the ecg signal is poor (ecg artifact) or if the leads are disconnected (electrodes off) and therefore, no arrhythmia alarms would be provided until the technical issue is resolved.There was no device malfunction, the expected alarms were provided at the m300 and ics during the event.
Event or Problem Description
It was reported that a patient was monitored with a telemetry device; the heart rate displayed at the central monitoring station (cms) was 86bpm.A nurse was with the patient until 9:10 pm.The patient had a heart attack within the next few minutes; the bed neighbor called the nurse at 9:14.Unfortunately, the initiated resuscitation efforts were not successful, the patient died.

• Brand Name: M300
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 2156602400
• MDR Report Key: 18397123
• Report Number: 1220063-2023-00056
• Device Sequence Number: 14444884
• Product Code: MHX
• UDI-Device Identifier: 04049098048989
• UDI-Public: (01)04049098048989(11)210405(91)VG2.3.1(93)MS25755-30
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: MS25755
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 10/21/2024; 10/24/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 10/22/2024; 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2021
• 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 Sex: Unknown