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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 08feb2019.Serial number unknown.A follow-up report will be submitted once the investigation is completed.

Event Description

The customer contacted philips technical support (ts) stating that the unit had a battery failure.The device was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or user.The event date was not specified; estimate used.

Manufacturer Narrative

Date rec¿d by mfr : 31jul2019, date of report : 02aug2019.Repair information was confirmed.Failure investigation was completed.There was no patient involvement.The fse replaced the power management (pm) printed circuit board assembly (pcba) and the battery to address the reported issue.The pm pcba was installed into a test ventilator in attempt to duplicate the reported problem.Further investigation did not confirm any failures with the pm pcba.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: 8323568
• MDR Text Key: 135702248
• Report Number: 2031642-2019-00816
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

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: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2019
• 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
• Supplement Dates FDA Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PATIENT CIRCUIT, MASK, HUMIDIFIER: UNKNOWN