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

Model Number V60

Device Problem Battery Problem (2885)

Patient Problem No Information (3190)

Event Date 02/17/2021

Event Type  malfunction  

Event Description

It was reported that the ventilator spontaneously shut off without there having been any messages about the battery almost being drained.Although requested, it is unknown if the patient was connected to the ventilator at the time of the event.No harm reported.

Manufacturer Narrative

G4:(b)(6) 2021.B4: (b)(6) 2021.Although requested, it is unknown if the patient was connected to the ventilator at the time of the event.Multiple attempts were made to obtain additional information that have been unsuccessful.The customer was sent a quote for service/ repair that was not accepted.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• MDR Report Key: 11418377
• MDR Text Key: 242581242
• Report Number: 2031642-2021-03005
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838009851
• UDI-Public: 00884838009851
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup

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: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053614
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/17/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2021
• Supplement Dates Manufacturer Received: 05/18/2021
• Supplement Dates FDA Received: 06/15/2021
• Date Device Manufactured: 04/16/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1