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

Model Number V60

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Shut Off (2939)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of this report: 03 mar 2020.

Event Description

The customer reported that the following diagnostic codes were found in the error log: "auxiliary alarm supply failed", "35 v supply failed", "backup alarm failed", "ventilator restarted due to anomalies detected during operation", and "cooling fan speed error".The customer also reported that the touchscreen was functioning, but it would not allow the ventilator to be turned off.Finally, they reported the battery is low and cooling is intermittently turning on and off.There was no patient involvement.The customer confirmed the reported problems.The customer replaced the power management board.The error codes and the problem regarding the device being unable to turn off via the touch screen were resolved.The battery and cooling issue are pending resolution.

Manufacturer Narrative

G4: 01apr2020.B4: 02apr2020.H10: b1 and h1 updated: it is unknown if the device was in use at the time of the event.Due to limited information provided, provision of medical intervention to prevent/preclude harm is unclear and therefore has not been ruled out.Assessment of complaint with this assumption has been considered via clinical risk review and shall be reported as serious injury.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: 16apr2020.B4: 20apr2020.H11: b1 and h1 correction: the device was being set up for treatment when the reported event occurred; however, it was not in use on a patent and there was no patient harm.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: 23mar2020.B4: 24mar2020.The customer reported that the ventilator is now successfully charging after allowing it to charge overnight.No other information was received after multiple attempts were made.If new information is obtained a supplemental report will be submitted.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: 17mar2020 b4: (b)(6)2020.The customer did not respond to requests for additional information on the battery and cooling issue.If further information is obtained, this complaint will be reopened.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: 9781973
• MDR Text Key: 192170359
• Report Number: 2031642-2020-00731
• 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,Followup,Followup,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1