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

Model Number V60

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 02/26/2021

Event Type  malfunction  

Event Description

The customer reported a defective cpu (central processing unit) that needs replacement.The customer did not report any patient involvement.

Manufacturer Narrative

G5: 510k: k102985.B4: (b)(6) 2021.The customer called into technical support (ts) reporting that the device is displaying error 100b (post) (vent-inoperative): watchdog test failed.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed reported problem.The customer advised he replaced the cpu pcb, mc pcb, flow sensor assembly and swapped out the ribbon cable from the da pcb to mc pcb and still has the same issue.The rse advised customer the v60 option codes and v60 will need to be restored after replacing the cpu board.The rse provided the customer with the option codes for restoring.The customer requested onsite service.It turned out that the customer received a faulty flow sensor from philips.The customer replaced flow sensor to resolve reported problem.The device passed required performance verification tests per philips standards and was put back into service.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• MDR Report Key: 11579824
• MDR Text Key: 243173149
• Report Number: 2031642-2021-03148
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2021
• 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
• Distributor Facility Aware Date: 02/26/2021
• Date Manufacturer Received: 07/08/2021
• Date Device Manufactured: 08/31/2018
• 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