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

Model Number V60

Device Problem Intermittent Loss of Power (4016)

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

Event Date 12/27/2021

Event Type  malfunction  

Event Description

The biomed customer called into technical support (ts) reporting that the ventilator is intermittently shutting off and they need a part number for a new pcba pcu.The device was in use at the time the reported issue was discovered; however, there was no harm to the patient or user.The v60 shut down without any alarm the screen went black then came back online within a span of about 30 seconds.After it came back online it then was immediately swapped out.No adverse reaction from the patient involved nor medical intervention provided.There was only a delay within the time it took to replace the device with no harm to the patient.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.It was determined that the caller was attempting to order a cpu with 3.00 installed which is not yet available.The customer was provided with the part id for cpu with 2.30 and advised it will need updated.It was determined that the cpu is being replaced due to a 1101 code.The customer replaced the pcba cpu to resolve the reported issue.The device passed required performance verification tests per philips¿s standards.

Manufacturer Narrative

The removed cpu board was returned to the failure investigation lab (fi).A visual inspection of the cpu board revealed no evidence of damage or contamination.The fi technician installed the cpu board into a fi ventilator to duplicate the reported issue.The cpu board was tested, and no failures were identified.The 1101 error code could not be duplicated.

• 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: 13285111
• MDR Text Key: 287346019
• Report Number: 2031642-2022-00177
• 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: Health Professional
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/27/2021
• Initial Date FDA Received: 01/18/2022
• Supplement Dates Manufacturer Received: 05/19/2022
• Supplement Dates FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2013
• 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