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

Model Number	MS18852
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	07/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Event or Problem Description
It was reported that a patient was being monitored with a draeger infinity gamma xxl patient monitor connected to the draeger infinity centralstation (ics).Ecg and hf changes occurred, the patient became bradycardic.Alarms of hf and spo2 disconnection were not audible.An alert was given for arrhythmia via the asystole alarm.The patient was successfully reanimated.
Event or Problem Description
It was reported that a patient was being monitored with a draeger infinity gamma xxl patient monitor connected to the draeger infinity centralstation (ics).Ecg and hf changes occurred, the patient became bradycardic.Alarms of hf and spo2 disconnection were not audible.An alert was given for arrhythmia via the asystole alarm.The patient was successfully reanimated.
Additional Manufacturer Narrative
Subsequent to the event, a function test of the ecg was performed.Appropriate alarms were provided acoustically and visually both at the gamma xxl and at the ics.Review of the ics logs provided show that prior to the asystole alarm provided at 5:02 on the date of the event, starting at 2:05, two "hf > 145" alarms and five "ecg signal invalid alarms" were provided.At 3:36 the alarms were turned off by the user at the ics which accounts for the report of no audible alarms being provided.As indicated in the ics instructions for use, you can individually enable or disable the alarm function for all parameters.Certain high-grade alarms such as asy and vf can be disabled only by accessing special settings and normally will always remain enabled.No device malfunction was identified.

• Brand Name: INFINITY GAMMA XXL
• Common Device Name: 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: 17410211
• Report Number: 1220063-2023-00020
• Device Sequence Number: 20613317
• Product Code: MHX
• UDI-Device Identifier: 04049098050067
• UDI-Public: 04049098050067
• Combination Product (Y/N): N
• PMA/510(K) Number: K070566
• 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,Followup
• Report Date (Section B): 10/04/2023

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
• Operator of Device: Health Professional
• Device Model Number: MS18852
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2010
• 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: Required Intervention
• Patient Sex: Unknown