MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VM 4 PATIENT MONITOR; COMPACT PORTABLE PATIENT MONITORS

Model Number 863063

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported speaker not working.It was reported that the event did not result in death or serious injury.

Event Description

The customer reported speaker not working.The device was not connected to a patient.

• Brand Name: SURESIGNS VM 4 PATIENT MONITOR
• Type of Device: COMPACT PORTABLE PATIENT MONITORS
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8248090
• MDR Text Key: 133182827
• Report Number: 1218950-2019-00459
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838000032
• UDI-Public: (01)00884838000032
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2018

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: 863063
• Device Catalogue Number: 863063
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2018
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 12/28/2018
• Supplement Dates FDA Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1