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

Model Number	V60
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: (b)(6) 2020.
Event or Problem Description
The customer reported battery ordered, did not display the manufacture date in the pneumatics screen.The unit was in clinical use at the time the reported issue was discovered.However, there was no patient harm reported.
Additional Manufacturer Narrative
G4: 10sep2020, b4: 14sep2020.The battery was returned by the customer and a replacement order for the customer was confirmed.The reported problem was duplicated and confirmed by a philips failure investigation (fi) technician.The visual inspection showed that a battery had been received with no anomalies noted.Furthermore, a failure investigation (fi) technician installed returned battery into a fi ventilator to duplicate the reported issue of a battery ordered not displaying the manufacture date in the pneumatics screen.Fi technician identified the failure of the battery to display the manufactured date on the ventilator is due to corrupt data on the battery eeprom.This is further supported by the erroneous gas gauge report of a maximum lifetime temperature of 292 degrees celsius that was pulled from the battery.The battery cells appear to be in good health according to charging measurements provided by r&d.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
• Common Device Name: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 9947070
• Report Number: 2031642-2020-01267
• Device Sequence Number: 11460585
• Product Code: MNT
• UDI-Device Identifier: 00884838020429
• UDI-Public: 00884838020429
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K082660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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
• Operator of Device: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER