MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP90 INTELLIVUE PATIENT MONITOR; COMPACT PATIENT MONITOR

Model Number M8010A

Device Problem No Audible Alarm (1019)

Patient Problem Death (1802)

Event Date 02/07/2021

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

The customer reported on (b)(6) 2021, their intellivue mp90 failed to alarm for a patient incident.The patient expired.

Manufacturer Narrative

H10: a philips field service engineer (fse) went to the customer, and tested the functionality of the mp90.A basic performance test was performed, (using the biomed simulator).The results of the basic performance test confirmed the following: each parameter (resp, ecg, spo2) was displayed and working properly on the monitor.The blue, yellow and red alarms were validated, and alarm inops were displayed along with the inop sounds being emitted from the monitor.It was further verified the alarm inop lights were displaying and flashing per their color.A visual inspection test was performed and confirmed the following: validation of alarm sounds and lights, along with confirming the device housing, speaker and network cable were functioning as intended.A power-on test was performed, by turning the monitor off / on which confirmed all parameters were displayed.All tests performed on the device passed with no failures identified.A philips solutions support engineer (sse) reviewed the piic red log and the recorder manager log which showed alarms, staff silencing and recordings showing multiple alarming events.The fse confirmed an alarm was issued from the bedside (icu114) at 06:30:46, and was silenced 23 seconds later at 06:31:09.It was not identified where the alarm was silenced (bedside or central).Icu114 continued to alarm and be silenced off and on until 07:22.There was no product malfunction.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: MP90 INTELLIVUE PATIENT MONITOR
• Type of Device: COMPACT PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 11329858
• MDR Text Key: 231934055
• Report Number: 9610816-2021-00052
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K030038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

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
• Device Operator: Health Professional
• Device Model Number: M8010A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 02/15/2021
• Supplement Dates Manufacturer Received: 02/09/2021
• Supplement Dates FDA Received: 03/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death