MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number BIPAP FOCUS VENTILATOR

Device Problem Unexpected Shutdown (4019)

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

Event Date 02/20/2024

Event Type  malfunction  

Event Description

Philips received a complaint from the customer biomedical engineer (bme) reporting bipap focus ventilator shut down while the device was in clinical use.There was no report of harm.The patient was transferred to a v60 ventilator to continue therapy.The device was removed from service.A philips remote service engineer (rse) evaluated the issue with bme and confirmed the device logged error 436 cbit indicating a18volt boost monitor failure.The rse referred the bme to troubleshooting recommendations found in the bipap service manual.The rse also provided customer with the end of support documentation for the bi-pap focus ventilator.The discontinuance letter was released july 21, 2014, and noted support would continue for 5 years after the discontinuance date of december 31, 2014.Accessories, supplies, upgrades, and parts associated with the bipap focus ventilator were made available only through the end of support date of december 31, 2019.No repair was performed by philips service.The investigation concludes that no further action is required at this time.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18875190
• MDR Text Key: 337349388
• Report Number: 2518422-2024-13152
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• 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 VENTILATOR
• Device Catalogue Number: 1028772
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/11/2024
• Date Device Manufactured: 08/25/2011
• 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