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 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.

Event Description

The customer reported that alternating current (ac) power cord was not charging the unit.The device was not in use on a patient.No patient or user harm was reported.The remote service engineer (rse) confirmed there was no (ac) power getting through the cord.The investigation is ongoing.

Manufacturer Narrative

The customer replaced the power cord with a new one.The unit was tested, and it was returned to service.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• MDR Report Key: 12337730
• MDR Text Key: 267109200
• Report Number: 2031642-2021-04611
• 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
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• 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: 07/22/2021
• Date Manufacturer Received: 08/23/2021
• Date Device Manufactured: 07/13/2009
• 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