MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VSI - NBP/SPO2

Model Number 863276

Device Problem No Audible Prompt/Feedback (2282)

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

Event Date 08/11/2022

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported the problem of speaker failure alarm.The device was not in use.

Manufacturer Narrative

A field service engineer(fse) was dispatched to the customer's site.The fse was told that the equipment was not found by the emergency service when it appears, they will retain it in storage room 7 and will report it again.A good faith effort was made to see if there's any new information on whether the device was located, but there is no additional information available.The customer was not able to locate the device.Therefore, we are unable to determine the cause of the problem.The device remains at the customer's facility.No further action or investigation is warranted based on the available information at the time of complaint closure.

Event Description

The customer reported the problem of loudspeaker failure alarm.The device was not in use on a patient at the time of the event.

• Brand Name: SURESIGNS VSI - NBP/SPO2
• Type of Device: SURESIGNS VSI - 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15270053
• MDR Text Key: 300324701
• Report Number: 1218950-2022-00810
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00884838028371
• UDI-Public: 00884838028371
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K112652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 863276
• Device Catalogue Number: 863276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/22/2013
• 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