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

Model Number V60

Device Problem Failure to Charge (1085)

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

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

Date of report: 28jun2021.There was no patient involvement.

Event Description

The customer reported that the battery is not charging even after replacement.The ventilator is running on battery even when plugged into ac power.There was no patient involvement.The remote service engineer (rse) advised the customer the power management (pm) board may need to be replaced.Other information is still pending.

Manufacturer Narrative

Many good faith efforts were made to obtain additional information from the customer; however, there was no response.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• MDR Report Key: 12079379
• MDR Text Key: 259110641
• Report Number: 2031642-2021-04202
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• 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
• Distributor Facility Aware Date: 06/02/2021
• Date Manufacturer Received: 10/08/2021
• Date Device Manufactured: 11/04/2010
• 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