MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS VS4 VITAL SIGNS MONITOR; PATIENT MONITOR

Model Number 863283

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported faulty speaker - audio.No patient involvement.

• Brand Name: VS4 VITAL SIGNS MONITOR
• Type of Device: PATIENT MONITOR
• 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: 8645248
• MDR Text Key: 146261565
• Report Number: 1218950-2019-03841
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00884838087095
• UDI-Public: (01)00884838087095
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K120132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

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: 863283
• Device Catalogue Number: 863283
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 05/28/2019
• Supplement Dates Manufacturer Received: 05/15/2019
• Supplement Dates FDA Received: 07/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2018
• 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