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

Model Number V60

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2018.Date of report: 15nov2018.(b)(4).A final report will be submitted upon completion of the investigation.

Event Description

The customer reported blower stalled the device was not in use at the time of the reported event; therefore, there was no patient involvement.The event date was not specified; estimate used.

Manufacturer Narrative

Date of report: 19dec2018.Date of manufacturer: 18dec2018.The customer was provided with details on repairing the device themselves or sending in unit for repair.Numerous attempts were made to contact the customer to obtain information regarding the repair of the device, however, no response was received.Should additional information be obtained, a supplemental report will be filed.

Manufacturer Narrative

Date rec'd by mfr: 15march2019.Method, results, conclusion.The customer replaced the blower to address the reported problem.The unit successfully passed the required performance verification test.A blower motor assembly was returned to the failure investigation (fi) lab for evaluation.Visual inspection of the blower motor assembly revealed no signs of damage or contamination to the exterior of this unit.There were no signs of damage or contamination to the impeller, surrounding area, end cap, or the end cap o-ring.Operational testing was performed and cycling the power did not produce any failures, the test ventilator did boot up and deliver breaths, and no errors were generated during approximately 4 hours of operation with the blower running.This customer returned v60 blower assembly was tested and no failures were identified.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• 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
• MDR Report Key: 8076785
• MDR Text Key: 127553656
• Report Number: 2031642-2018-02545
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1