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

Model Number V60

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 08feb2019.Reporter phone number unknown.The customer did not approve repair of the device.Reportedly, the device would not be returned to service.No parts were returned to philips for analysis, therefore, a root cause could not be established.

Event Description

It was reported that the unit failed air flow accuracy testing following replacement of the power management board.There was no patient involvement.The event date was not specified; estimate used.

Manufacturer Narrative

G4: 04feb2020.B4: (b)(6) 2020.The manufacturer's field service engineer (fse) revisited the customer's site and found that the unit declared a backup alarm failure as well as a battery failure.The customer also later reported that the unit declared a proximal pressure sensor autozero failed error.The fse replaced the flow sensor, data acquisition board, battery and solenoid valve to address the reported issues.The data acquisition board was returned for failure analysis.A visual inspection revealed no signs of damage or contamination.During testing, 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.

Manufacturer Narrative

G4: 28feb2020 b4: (b)(6)2020.The gas delivery system (gds) was returned for failure analysis.A visual inspection revealed that the unit was received without the data acquisition (da) board and oxygen valve.The ribbon cable connecting the flow sensor to the da board was twisted and punctured.During testing, the unit failed due to the air flow sensor caused by the u1 component being out of specification.The unit did not declare a proximal pressure autozero failure.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: 8322922
• MDR Text Key: 135697414
• Report Number: 2031642-2019-00811
• 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: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2019

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: No Information
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 01/18/2019; 01/18/2019
• Supplement Dates FDA Received: 02/06/2020; 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1