MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP70 INTELLIVUE PATIENT MONITOR

Model Number M8007A

Device Problem Device Fell (4014)

Patient Problem Head Injury (1879)

Event Date 10/20/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that the monitor fell and hit a patient.The patient had a head wound which required stitches.

Manufacturer Narrative

H3 and h6: the customer reported that on (b)(6) 2019 at 2:30 am the intellivue mp70 patient monitor for icu bed 6 fell and hit a patient.The patient had a head wound which required stitches.A field service engineer (fse) went for onsite service and confirmed the reported issue.During the investigation of the intellivue mp70 the fse found that the quick release button was not fully normalized after being depressed.The issue was intermittent but when the quick release button did not come to rest flush against the bottom casing the monitor was not secure.A video of the quick release button was provided by the fse.After the replacement of the quick release mount the device returned to full functionality.Product support engineering requested the faulty quick release mount for further investigation, however, the customer refused to return the quick release mount to philips.The customer's issue was caused by a malfunction of the device.The problem was solved by replacement of the 453564227351 iv- mp70 mechasy quick release mount kit, which is considered as all that is warranted for this malfunction.The exact cause for the reported issue remains unknown, as the customer refused to send the part for further investigation.The repaired product remains at the customer site.No subsequent calls have been logged for this device/issue.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: MP70 INTELLIVUE PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 9237319
• MDR Text Key: 163889696
• Report Number: 9610816-2019-00283
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K021300
• 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: 10/21/2019

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: M8007A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 10/21/2019
• Supplement Dates FDA Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other