MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP30 INTELLIVUE PATIENT MONITOR; COMPACT PATIENT MONITOR

Model Number M8002A

Device Problem Device Alarm System (1012)

Patient Problem Loss Of Pulse (2562)

Event Date 03/17/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported on (b)(6) 2020 their intellivue mp30 monitor did not print a non-sustained vt yellow alarm.The patient entered asystole state.Cpr was given to revive the patient.

Manufacturer Narrative

H3 and h6 : the customer biomed spoke with the hospital physician who felt the mp30 monitor should have alarmed for the non-sustained vt event.The biomed explained to the physician the device printed on red asystole alarm as it was configured.There was no onsite philips engineer evaluation of the reported failure.A philips field service engineer (fse) spoke by telephone with the customer biomed who confirmed the issue has been resolved.The customer biomed stated that in-service training will be occurring to ensure that the hospital staff understands how the monitor alarming works.There was no malfunction of the reported alarm.The available information and investigation findings support that there is no design, manufacturing, materials or labeling problem, therefore no further investigation, action or communication is warranted.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: MP30 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: 9915242
• MDR Text Key: 186108036
• Report Number: 9610816-2020-00113
• 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: 03/19/2020

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: M8002A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2020
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 03/19/2020
• Supplement Dates FDA Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention