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

Model Number V60

Device Problem Failure of Device to Self-Test (2937)

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

Event Date 08/30/2022

Event Type  malfunction  

Event Description

Customer reports that the ventilator is alarming primary alarm failure.Device gives a constant 1102 power on self test (post) primary alarm failure.No patient involvement.There was no report of patient or user harm.The remote service engineer (rse) discussed troubleshooting steps per the service manual.Provided parts id for the speaker assembly and cpu pcba.

Manufacturer Narrative

Customer replaced speaker assembly and tested units for performance specification successfully.Removed speaker assembly was disposed of by customer.

• 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: 15439276
• MDR Text Key: 304914899
• Report Number: 2031642-2022-02428
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• 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: Biomedical Engineer
• 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?: Yes
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 10/19/2022
• Supplement Dates FDA Received: 10/24/2022
• Date Device Manufactured: 12/06/2011
• 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