MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP60 INTELLIVUE PATIENT MONITOR; COMPACT PATIENT MONITOR

Model Number M8005A

Device Problem Failure to Power Up (1476)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported intellivue mp60 monitor turned off and cannot be turned back on.The patient suffered hypotension.No further information regarding a contribution of the device to the reported event was available at the time of the initial report.

Manufacturer Narrative

H3 and h6: a philips field service engineer (fse) went to the customer site and downloaded the log files from the monitor.The device log files showed the monitor had an application data error which caused the monitor to shutdown unexpectedly.The nursing staff was not able to confirm if the monitor had alarmed prior to the shutdown.The investigation findings determined that this is a user workflow issue / user misunderstanding.The hypotension occurred when the hospital staff changed the ventilator (in order to maintain the anesthesia).The user made changes to the patient environment because they could not determine where an alarm sound was emanating from.The hospital site has installed a replacement monitor to the complete the intervention.The device remains out of service and is with the biomedical department at the customer site.There is minimal health risk.No further investigation or action is warranted at this time.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: MP60 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: 9801811
• MDR Text Key: 182429649
• Report Number: 9610816-2020-00076
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M8005A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 55