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

Model Number V60 VENTILATOR,JAPAN OPT: CFLEX,AVAPS

Device Problem Disconnection (1171)

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

Event Date 08/03/2021

Event Type  malfunction  

Event Description

The customer reported that a ventilator gave a patient disconnect alarm message.The device was evaluated by the customer and a philips field service engineer (fse).A functional test was performed and no abnormality was confirmed.The device was in clinical use at the time the issue was discovered.The unit was replaced with the same model and no other medical intervention was reported.The patient information was not disclosed.There was no patient or user harm reported.There was no delay to patient therapy reported.

Manufacturer Narrative

A functional test was performed and no abnormality was confirmed.No parts need to be replaced.No other anomalies have been reported, however, the fse is waiting for an order from the customer, the repair completion date has not been fixed.

Manufacturer Narrative

The customer cancelled the repairs, therefore, the device was returned unrepaired.No parts were replaced.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 12393748
• MDR Text Key: 268996602
• Report Number: 2031642-2021-04757
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,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 Model Number: V60 VENTILATOR,JAPAN OPT: CFLEX,AVAPS
• Device Catalogue Number: 1053618
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/03/2021
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 10/22/2021; 11/01/2021
• Supplement Dates FDA Received: 10/25/2021; 11/24/2021
• Date Device Manufactured: 03/07/2012
• 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