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

Model Number V60

Device Problems Material Discolored (1170); Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019, date of report: 11/13/2019.

Event Description

During periodic maintenance of the ventilator, the manufacturer¿s international service technician reported that the alternate current (ac) cord was pulled out for pre-use check.Then, a spark occurred and the tip of the ac cord burned black.Reportedly, the device had always been connected to a socket for emergency at the equipment room of the emergency center.Just when a nurse was about to disconnect the device from ac in order to use it, a spark flew out.The power cord of the device and the socket for emergency burned black.There was no patient involvement.

Manufacturer Narrative

Pma/510k: 29nov2019.Date of report: 03dec2019.The manufacturer¿s international service technician inspected the device and found the issue was caused by occurrence of short circuit between the terminals of the power cord.Performed a test run and functional test after replacing the power cord and confirmed there was no abnormality, all tests passed.The determination could not be made that the device failed to meet specifications.The device was not being used for treatment when the reported event occurred, and there is a relationship of the device to the reported problem.No parts were returned to failure investigation; therefore, the root cause of the reported issue could not be determined.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: (b)(6) 2020.B4: (b)(6) 2020.An alternation current (ac) power cord was returned for analysis.A visual inspection of the returned component was performed and found that the plug end, the line and neutral contacts have been damaged by electrical stress event(s) and rapid oxidation.An investigation was performed and the product analysis technician reported that the returned ac cord was damaged beyond repair.No short circuit exists between any conductors at the time of this testing, and the resistance of each wire is within specification.Root cause cannot be determined.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: 9319213
• MDR Text Key: 179395609
• Report Number: 2031642-2019-10513
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1