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

Model Number 863283

Device Problem High Test Results (2457)

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 reported the problem of inaccurately high spo2 readings.The device was in clinical use.There was no reported patient or user impact.

Manufacturer Narrative

H10: the customer contacted the customer care solutions center(ccsc) for troubleshooting/evaluation of the device.The ccsc advised customer to turn off and on the spo2 option but the problem still persists.The ccsc then advised customer to replace the spo2 board and provided part number 453564020531 ss pca spo2.Per the case notes, the customer stated to close the case as it will take weeks to get the part and a few weeks to do the repair.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: VS4 VITAL SIGNS MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11338907
• MDR Text Key: 233467890
• Report Number: 1218950-2021-00870
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00884838087095
• UDI-Public: (01)00884838087095
• Combination Product (y/n): N
• PMA/PMN Number: K120132
• 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: 02/03/2021

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1