MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VS3 NBP, SPO2, TEMP

Model Number 863073

Device Problem No Audible Alarm (1019)

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

Event Date 08/02/2023

Event Type  malfunction  

Manufacturer Narrative

The biomed was instructed to run alarm testing, which had generated alarm sounds.Results of functional testing indicate that the device was in fact sounding alarms as designed.Based on the information available and the testing conducted the biomed tech was unable to replicate the reported problem after the remote service engineer instructed the biomed tech to restart the device.The device was operational after restart.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Event Description

Philips received a complaint on the suresigns vs3 nbp, spo2, temp (863073), indicating that there was a speaker malfunction.There was no patient harm or death involving this device.

• Brand Name: SURESIGNS VS3 NBP, SPO2, TEMP
• Type of Device: SURESIGNS VS3 NBP, SPO2, TEMP
• 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: 17623301
• MDR Text Key: 321942859
• Report Number: 1218950-2023-00602
• Device Sequence Number: 1
• Product Code: DSJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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: 863073
• Device Catalogue Number: 863073
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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