MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number BIPAP FOCUS SYSTEM, INT'L, RENTAL

Device Problem Power Problem (3010)

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

Event Date 07/11/2022

Event Type  malfunction  

Event Description

It was reported to philips the device gave error code 432 - 3.3v voltage rail failed.This event was reported to have occurred during patient use.The device was exchanged for another device.There was no patient harm.The customer spoke with a philips remote service engineer (rse).The rse informed the customer that the device is no longer supported.Philips no longer support accessories, supplies, upgrades, and repair support parts associated with the bipap focus.  the end of support date for bipap focus ventilator is 31st december 2019.No further information was provided to the customer.The customer has retired the device from service.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: kimberly shelly ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 15115854
• MDR Text Key: 302354653
• Report Number: 2031642-2022-01974
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial

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: BIPAP FOCUS SYSTEM, INT'L, RENTAL
• Device Catalogue Number: R1033869
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 07/27/2022
• Date Device Manufactured: 03/25/2008
• 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