MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VS4 NBP, SPO2

Model Number 863283

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2021

Event Type  malfunction  

Event Description

The customer reported that the philips vs4 device support is broken and the monitor can't be hung.It is unknown if the device was in use at time of event, no report of adverse event or patient impact reported.

Manufacturer Narrative

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

Event Description

The customer reported that the device has suffered a fall, the monitor support is damaged and cannot be used.It is unknown if the device was in use at time of event, no report of adverse event or patient impact reported.

• Brand Name: SURESIGNS VS4 NBP, SPO2
• Type of Device: SURESIGNS VS4 NBP, SPO2
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12975886
• MDR Text Key: 282047976
• Report Number: 1218950-2021-11162
• Device Sequence Number: 1
• Product Code: DSJ
• UDI-Device Identifier: 00884838087095
• UDI-Public: 00884838087095
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K163649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• 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
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2018
• 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