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

Model Number V60

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 05/05/2021

Event Type  malfunction  

Manufacturer Narrative

Date of report: 02jun2021.There was no patient involvement.

Event Description

The customer reported that the unit is alarming check vent blower stalled.The customer contacted product support and requested for service repair.The customer reported that the unit was not in use on patient.

Manufacturer Narrative

The customer reported the device was in use on a patient.The patient was placed on an alternate vent.There was no patient harm noted.Following the evaluation of the device, the field service engineer replaced the blower and flow sensor assembly to resolve the problem.The unit was then functionally tested and successfully passed specified tests.No other abnormality was observed.

Manufacturer Narrative

A gas delivery system (gds) assembly was returned for analysis.Visual inspection of the gds assembly revealed no obvious dust or debris on the unit.Failure investigation (fi) was performed, and the customer complaint was verified.The returned blower is seized and will not deliver air.The root cause is failure of the motor shaft.

• 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: 11925006
• MDR Text Key: 254035719
• Report Number: 2031642-2021-03936
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 10/02/2021

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
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/05/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 09/03/2021; 01/03/2022
• Supplement Dates FDA Received: 10/02/2021; 03/08/2022
• Date Device Manufactured: 09/20/2013
• 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