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

Model Number V60

Device Problems Failure to Charge (1085); Failure to Run on Battery (1466)

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

Event Date 02/02/2022

Event Type  malfunction  

Event Description

The biomedical engineer reported that the v60 device is not charging the battery.There was no patient involvement at the time the reported issue occurred.There was no report of patient or user harm.The biomedical engineer (bme) reported that the v60 battery voltage is at approximately 9 volts and will not run on battery.The bme also reported that the amber ac power light is on, and that the unit only has 55 hours of running time.The remote service engineer advised the bme to let the unit charge 48 hours and check the battery voltage again.An onsite work order was created for warranty repair.The authorized service provider replaced the battery and the power management board to resolve the issue.

Manufacturer Narrative

The battery was returned for failure analysis.No anomalies noted on returned unit during visual inspection.Testing was performed, the ventilator cannot start with this battery as the only power source.The customer complaint was duplicated.The root cause cannot be determined without opening the battery package.The battery will be returned to manufacturer for analysis.

Manufacturer Narrative

The power management (pm) pcba was returned for failure investigation.All tests for the pm board passed and the complaint was not duplicated.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 13674362
• MDR Text Key: 286947753
• Report Number: 2031642-2022-00596
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2021
• 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