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

Model Number V60

Device Problems Intermittent Continuity (1121); Loss of Power (1475); Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.

Event Description

The customer reported that the ventilator will intermittently turn on and off.The battery was also depleted.The device was not being used for treatment when the reported event occurred and there was no patient involvement.The fse (field service engineer) evaluated the device and confirmed the reported problem.The service technician replaced the power management board and power supply and the reported problem was resolved.The ventilator was calibrated successfully and passed all required testing.The battery still needs to be replaced.

Manufacturer Narrative

G4: 21apr2020.B4: 23apr2020.The service technician replaced the battery.The ventilator was calibrated successfully and passed all required testing.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: 16sep2020.B4: 25sep2020.A battery was returned for analysis.A visual inspection of the returned component was performed, and no notable conditions were found.The returned component was installed into a test ventilator for analysis.An investigation was performed and the product analysis technician reported that the reported problem could not be replicated.Battery was received with depleted charge.No fault was found with the battery.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: 9965735
• MDR Text Key: 188273556
• Report Number: 2031642-2020-01351
• 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: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2020

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: 06/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 04/15/2020
• Supplement Dates Manufacturer Received: 03/25/2020; 03/25/2020
• Supplement Dates FDA Received: 04/23/2020; 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1