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

Model Number V60

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 30dec2019.

Event Description

The customer reported the ventilator's blower overheating.There was no patient involvement.

Manufacturer Narrative

G4: 31dec2019.B4: (b)(6) 2020.The fse (field service engineer) evaluated the device and confirmed the reported problem.The service technician replaced the motor controller printed circuit board.The ventilator was calibrated successfully and passed all required testing.The reported problem was resolved.The determination could not be made that the device failed to meet specifications.The device was not being used for treatment when the reported event occurred, and there is a relationship of the device to the reported problem.No parts were returned for failure investigation; therefore, the root cause at the component level could not be determined.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: 9533457
• MDR Text Key: 194172798
• Report Number: 2031642-2019-11008
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1