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

Model Number V200

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 08/17/2021

Event Type  malfunction  

Event Description

The customer reported ventilator alarm.The device was not in use on a patient.No patient or user harm was reported.

Manufacturer Narrative

The customer confirmed the reported failure.The customer refused repair from philips.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• MDR Report Key: 12423685
• MDR Text Key: 269835864
• Report Number: 2031642-2021-04816
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V200
• Device Catalogue Number: 1060264
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/17/2021
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 08/23/2021
• Supplement Dates FDA Received: 09/21/2021
• 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