MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS; PATIENT MONITOR

Model Number 863301

Device Problems Defective Device (2588); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer contacted the customer care solution center and alleged that the monitor on the complaint device was hanging up and requested support.The complaint device was not in clinical use at the time that the issue was discovered.

Manufacturer Narrative

H10: the field service engineer confirmed that the complaint device was fully functional and did not require repairs or additional configuration.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: PHILIPS
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10916014
• MDR Text Key: 219154771
• Report Number: 1218950-2020-07307
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838035218
• UDI-Public: (01)00884838035218
• Combination Product (y/n): N
• PMA/PMN Number: K151812
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 863301
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 11/28/2020
• Supplement Dates Manufacturer Received: 11/19/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1