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

Model Number V60

Device Problems Loose or Intermittent Connection (1371); Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 20may2020.

Event Description

The customer reported they needed to replace a battery.The field service engineer (fse) noted during his preventive maintenance an aged battery.He also encountered a nav-ring inop and power cord with intermittent connection.The (fse) replaced the aged battery.He also replaced the front bezel to fix the nav-ring issue.Finally, the power cord was replaced to fix the intermittent connection.The unit passes all testing and the unit has returned to service.The unit was not in use, and there was no patient harm.

Manufacturer Narrative

G4: 21sep2020.B4: 29sep2020.The power cord was returned to manufacturer to failure investigation (fi) for analysis.The reported problem could not be replicated.No fault was found with the returned power cord.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 no relationship of the device to the reported problem.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: 10077365
• MDR Text Key: 191978964
• Report Number: 2031642-2020-01784
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• 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: 08/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1