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

Model Number V60

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 08/16/2021

Event Type  malfunction  

Event Description

It was reported there was an alarm failure.Patient involvement is currently unknown.

Manufacturer Narrative

Many good faith efforts were made to obtain additional information; however, there was no response.The patient/user involvement and device evaluation are unknown.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• MDR Report Key: 12471682
• MDR Text Key: 271449150
• Report Number: 2031642-2021-04913
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838009844
• UDI-Public: 00884838009844
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/01/2021

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: No Information
• Device Model Number: V60
• Device Catalogue Number: 1053613
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 10/06/2021
• Supplement Dates FDA Received: 11/01/2021
• Date Device Manufactured: 06/18/2013
• 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