MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY M300; PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT

Model Number	MS25755
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Diminished Pulse Pressure (2606)
Date of Event	11/12/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
The date/time of the expected alarms was reported as (b)(6) 2022 19:00:00.The involved m300 and ics were tested on site by a draeger technician with no malfunctions identified.Review of the m300 (bed st34-15) alarm history shows 9 hf <45 and 14 asystole (asy) alarms were provided between 19:01:22 and 19:49:53 followed by a lead off at 19:51:24.Review of the ics logfiles show the audio pause button for bed st34-15 was initiated at the ics at 19:45.Review of the event information provided shows that as the patient heart rate decreased, multiple asystole alarms were provided as valid heartbeats continued with less and less frequency and finally no more heartbeats were detected after the last asystole alarm at 19:49:53.The ics/m300 instructions for use (ifu) provides the criteria for an asystole alarm as 4 seconds without a valid qrs (heartbeat) detected.Additionally the ifu provides the following warning the user must remain within the hearing range of the acoustic alarm signal.This operator position makes it possible to quickly detect an alarm and to respond accordingly.The distance to the medical device must be appropriate for the volume of the alarm signal.There was no device malfunction.
Event or Problem Description
It was reported that a patient was found dead in the room with an infinity m300 device, with battery installed and electrodes were all properly attached to the patient.The patient was found during the last rounds of the late shift.The patient already had death marks, the m300 did not alarm and despite the death marks, the m300 displayed a pulse of 21.It was noted that the infinity central station (ics) provided a hf alarm and that at the time of the incident, the staff was in the nursing round and therefore did not hear the alarm.Note that the infinity m300 generates alarms and provides them t the ics through the network.

• Brand Name: INFINITY M300
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA
• MDR Report Key: 15868703
• Report Number: 1220063-2022-00019
• Device Sequence Number: 17447726
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2022

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 Model Number: MS25755
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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