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

Model Number V60

Device Problems Battery Problem (2885); Therapeutic or Diagnostic Output Failure (3023); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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.

Event Description

Information was received via customer feedback stating the v60 device unexpectedly shut down, resulting in premature cessation of therapy delivery.The service engineer (se) inspected the device.The se found upon inspection that the unit powers on and cycles, but gives a ¿check vent battery failed¿ alarm message at start up.The se found the battery was heavily discharged and would not recharge.The se reviewed the ventilator diagnostic logs and noted that a significant timeframe from 1/28/2021 11:43 pm to 1/29/2021 7:18 am the unit ran on battery power the whole time until it finally shut off and power was restored again on 1/292021 7:41 am.It was also noted that the alarm volume was set at 2 during this run time.The customer biomedical engineer stated to believe this unit was plugged into a gfci (ground fault circuit interrupt) outlet that was tripped prior to use causing the unit to operate on battery only.The device was in clinical and therapeutic use at the time of the event.No report of harm or injury has been noted, nor provision of medical intervention to prevent permanent or life-threatening injury.The customer biomedical engineer replaced the battery and the unit was checked overall, run in tested, cleaned, functionally tested and no abnormality was confirmed.

• 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: 11418514
• MDR Text Key: 244197376
• Report Number: 2031642-2021-00843
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)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: user facility
• Type of Report: Initial
• Report Date: 02/04/2021

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: No Information
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1