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

Model Number V60

Device Problems Failure to Charge (1085); Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 18jun2020.

Event Description

The customer reported the battery failed.The customer indicated the unit powered on with out alternating current (ac) came up battery fail.The customer noted that the battery was down to 10 volts, swapped battery and it did not charge.The customer verified that the output voltage from the v60 is 14 volts and the battery was 2 years old.The voltage on the battery with the volt meter reads 0 volts.Swapped in another battery that displays 9.89 volts which this battery has been on shelf for 2 years.The customer has battery that the date reads 2017 and it will not charge either.Verified battery failed error code in the significant event log.The remote manufacture service technician advised the customer to replace the battery.The device did not have patient involvement at the time the issue was discovered, therefore, there was no patient or user harm reported.

Manufacturer Narrative

G4:04dec2020.B4:05dec2020.The customer confirmed the issue was resolved by replacing 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: 10171980
• MDR Text Key: 196226526
• Report Number: 2031642-2020-02139
• 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
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• 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: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1