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

Model Number BIPAP FOCUS SYSTEM, INT'L, RENTAL

Device Problem Improper Flow or Infusion (2954)

Patient Problem Insufficient Information (4580)

Event Date 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

Reporting institution phone number: (b)(6).Reporter phone number: (b)(6).

Event Description

It was reported that the ventilator was oscillating the airflow in both continuous positive airway pressure (cpap) and spontaneous with timed backup (s/t) mode.Additional information about the event has been requested.Although requested, it is unknown if the patient was connected to the ventilator at the time of the event.No harm reported.

Manufacturer Narrative

The customer was advised that the system is out of service and is at the end of life.No further information was provided.Multiple attempts were made to obtain additional information and device context at the time of the reported failure; however, no further details were provided philips no longer supports accessories, supplies, upgrades, and repair support parts associated with the bipap focus.The end of support date for the bipap focus ventilator is 31st december 2019.

• 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: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 12728177
• MDR Text Key: 279289854
• Report Number: 2031642-2021-05423
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K053168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• 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: BIPAP FOCUS SYSTEM, INT'L, RENTAL
• Device Catalogue Number: R1033869
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2021
• Initial Date FDA Received: 11/01/2021
• Date Device Manufactured: 07/14/2011
• 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