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

Model Number V60

Device Problem No Device Output (1435)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Submitted 29jan2021.

Event Description

It was reported to philips that the device's blower stalled.The device was reported as being in use at the time of the event on a patient.The initial reporter confirmed that there was no adverse patient impact.

Manufacturer Narrative

The device was reported as being in use at the time of the event on a patient.The patient was transferred to another ventilator.The initial reporter confirmed that there was no adverse patient impact.The philips field service engineer (fse) confirmed and duplicated the reported issue.Following the evaluation of the device, the fse replaced the blower assembly and the mc pcba to resolve the problem.The unit was then functionally tested and successfully passed specified tests.No other abnormality was observed.The blower motor assembly and mc pcba were returned to failure investigation for analysis.Visual inspection of the blower motor assembly revealed no evidence of damage or contamination.The reported issue was not confirmed.The blower motor assembly was tested, and no failures were identified.Visual inspection of the motor controller (mc) pcba revealed no evidence of damage or contamination.The reported issue was confirmed.The root cause was a failure of the u129 in the mc pcba.

• 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: 11255237
• MDR Text Key: 230458307
• Report Number: 2031642-2021-00374
• 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: 01/05/2022

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 Operator: Health Professional
• 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: 01/05/2021
• Initial Date FDA Received: 01/29/2021
• Supplement Dates Manufacturer Received: 11/15/2021
• Supplement Dates FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER