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

Model Number	MS18986
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.A draeger technician went on site and no malfunctions were identified.
Event or Problem Description
On 5 sep 2022 a complaint was received regarding an event where the involved patient died.There was an alleged report of a malfunction initially, but it was verified that alarms were manually turned off for the event.On 9 sep 2022 new information was received stating that the customer was alleging that the device not triggering an alarm during the event played a part in the patient outcome.
Event or Problem Description
On 5sep2022 a complaint was received regarding an event where the involved patient died.There was an alleged report of a malfunction initially, but it was verified that alarms were manually turned off for the event.On 9sep2022 new information was received stating that the customer was alleging that the device not triggering an alarm during the event played a part in the patient outcome.
Additional Manufacturer Narrative
The log images provided confirm the alarms were set to off for spo2, pls, fc, resp, ta, tb and cvp/min during the time of the event.The alarm history log image provided, shows two "resp apnea" alarms were generated and they were silenced/suspended by the user during the event.The vista xl was evaluated by a draeger technician on site and no malfunction with the device was identified.Additional information requested including ecg strips could not be made available.One picture provided, shows a non-draeger battery used with the monitor although this does not contribute to the reported issue.There was no device malfunction identified.H3 other text : a draeger technician went on site and no malfunctions were identified.

• Brand Name: INFINITY VISTAXL MONITOR
• 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: 15405519
• Report Number: 1220063-2022-00013
• Device Sequence Number: 6999762
• Product Code: MHX
• UDI-Device Identifier: 04049098003858
• UDI-Public: 04049098003858
• 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): 10/20/2022

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: MS18986
• Device Catalogue Number: MS18986
• 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: 09/05/2022
• Supplement Date Received by Manufacturer: 09/05/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2011
• 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