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

Model Number 863283

Device Problem Fire (1245)

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

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

The case indicates that the customer requested reprocessing and a check of the device after a fire.It is not known if the fire originated in the device or if the device was damaged in a fire at the hospital (originating outside of the device).A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer indicated that the device was contaminated by smoke and soot.Patient involvement is unknown.There was no report of a death or serious injury, nor was there a report of any adverse impact to any user or patient.

Event Description

The case indicates that the customer requested reprocessing and a check of the device after a fire.The customer indicated that the device was contaminated by smoke and soot.The device was not in use on a patient at the time of the event.

Manufacturer Narrative

The customer clarified that the philips device was not the source of the fire, but that the device was nearby where the fire occurred and may have been damaged as a result.The device was evaluated and it was determined that there were no negative impacts on the device as a result of the fire at the customer site.The device was visually inspected and functionally tested and there were no problems found.The device was returned to the customer and remains at the customer site.

• 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12422881
• MDR Text Key: 269812785
• Report Number: 1218950-2021-10892
• Device Sequence Number: 1
• Product Code: DSJ
• UDI-Device Identifier: 00884838087095
• UDI-Public: 00884838087095
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other
• Type of Report: Initial,Followup

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/24/2021
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 08/24/2021
• Supplement Dates FDA Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2018
• 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