MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 08/09/2021

Event Type  malfunction  

Event Description

It was reported to philips by a customer that the unit's speaker on the main board was not working.It is unknown if the unit was in use on a patient at the time of the reported event, however, no patient harm or injury was reported.It is unknown if any parts or repair has been conducted in relation to the alleged complaint.Attempts to obtain further information are currently pending.

Manufacturer Narrative

The field service engineer (fse) was dispatched to the site and confirmed the reported problem.The fse replaced the speaker assembly and power management pcba to resolve the reported issue.The unit was functionally tested and successfully passed all testing.The unit was returned to service.No other anomaly was reported.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 12435652
• MDR Text Key: 270316100
• Report Number: 2031642-2021-04840
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/09/2021
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 10/18/2021
• Supplement Dates FDA Received: 11/15/2021
• Date Device Manufactured: 08/21/2019
• 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