MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problems Defective Alarm (1014); Energy Output Problem (1431)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 26feb2021.

Event Description

The customer reported error codes saying blower stalled when the device was powered on.The errors were check vent: blower stalled or blower not running at required speeds, check vent: backup alarm failed, and check vent: aux alarm supply failed.There was no patient involvement.The customer spoke with a remote service engineer (rse) and confirmed.The errors were check vent: blower stalled or blower not running at required speeds, check vent: backup alarm failed, check vent: aux alarm supply failed, and check vent: 35 v supply failed in the error log.The rse advised to swap out the power management board or motor controller board to help diagnose the problem.The customer swapped the power management board and the issue was resolved.The customer requested onsite service for repair.

Manufacturer Narrative

The philips field service engineer (fse) replaced the power management (pm) printed circuit board assembly (pcba) which was replaced as part of field change order service.The unit was functionally tested and successfully passed all testing.The unit was returned to service.No other anomaly was reported.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RICA; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: yobana sanchez ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 11389290
• MDR Text Key: 242348515
• Report Number: 2031642-2021-00755
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082660
• 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
• Report Date: 08/09/2022

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 Model Number: V60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 08/08/2022
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2009
• 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