MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VS4 NBP, SPO2

Model Number 863283

Device Problem No Audible Alarm (1019)

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

Event Date 02/23/2024

Event Type  malfunction  

Manufacturer Narrative

A philips field service engineer (fse) went to the customer site and determined the speaker the did not work, and a loudspeaker alarm was triggered.The fse found that it was disassembled, and the speaker connector was loose.The fse reconnected the speaker connector cable.The cause of the reported problem was the connection of the speaker cable.The reported problem was confirmed.No part was replaced.The investigation concludes that no further action is required at this time.Reporting institution phone: (b)(6).Reporter phone: not provided.

Event Description

It was reported the speaker does not work and a loudspeaker alarm is triggered, the device was in clinical use at the time of the event, no adverse event or patient harm was reported.

• Brand Name: SURESIGNS VS4 NBP, SPO2
• Type of Device: SURESIGNS VS4 NBP, SPO2
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18886136
• MDR Text Key: 337442482
• Report Number: 1218950-2024-00154
• Device Sequence Number: 1
• Product Code: DSJ
• UDI-Device Identifier: 00884838028890
• UDI-Public: 00884838028890
• 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
• Report Date: 03/11/2024

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
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2017
• 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