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

Model Number V60

Device Problem Noise, Audible (3273)

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

Event Date 06/10/2022

Event Type  malfunction  

Event Description

The customer reported that a hissing sound was coming from the power supply.The customer reported that the unit was not in use on patient.The customer contacted product support and reported they had a v60 and there seemed to be a hissing sound coming from the power supply.The biomed disconnected the ac power and the noise goes away.Within seconds of reconnecting ac, the noise comes back.Since this unit is under the original warranty, the biomed requested onsite service.Product support recommend replacing the power supply.Part#: 453561540771, power supply.Further information has been requested.

Manufacturer Narrative

Per authorized service personnel (asp) the power supply was swapped, and the hissing sound went away.The proper tests were run for test & verification according to the service manual.

• 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: kimberly shelly ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 14802188
• MDR Text Key: 302796027
• Report Number: 2031642-2022-01692
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838090996
• UDI-Public: (01)00884838090996
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• 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
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 07/20/2022
• Supplement Dates FDA Received: 08/17/2022
• Date Device Manufactured: 10/16/2021
• 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