MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VM 8 PATIENT MONITOR

Model Number	863066
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted the customer care solution center and alleged an audio failure on the speaker of the complaint device.It was also reported that an spo2 failure had occurred and requested support.The complaint device was not in clinical use at the time that the issue was discovered.There was no adverse event or patient harm reported.

• Brand Name: SURESIGNS VM 8 PATIENT MONITOR
• Common Device Name: SURESIGNS VM 8 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11379024
• Report Number: 8043836-2021-00001
• Device Sequence Number: 3773915
• Product Code: MHX
• UDI-Device Identifier: 00884838000063
• UDI-Public: 00884838000063
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K123900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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
• Operator of Device: Health Professional
• Device Model Number: 863066
• Device Catalogue Number: 863066
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/08/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1