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

Model Number V60

Device Problems Failure to Charge (1085); Battery Problem (2885)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 07oct2020.

Event Description

It was reported that the unit alarmed to check the battery.There was no patient involvement.The field service engineer (fse) provided remote support and through troubleshooting determined the backup battery was not charging.The fse instructed the customer to run on battery power per the pvt battery test and if after 20 minutes of running on battery the battery does not charge then to replace the power management board.

Manufacturer Narrative

Following the evaluation of the device, the field service engineer (fse) recommended replacing the battery.Multiple attempts were made to follow up with the customer to obtain repair information; however, there was no response.If additional information is received at a later date, a supplemental report will be submitted.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; carlsbad CA
• Manufacturer Contact: bill cole ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 10645937
• MDR Text Key: 211474938
• Report Number: 2031642-2020-03628
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2011
• 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