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

Model Number CN1167HS

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 06/11/2021

Event Type  Death  

Event Description

The manufacturer received information alleging a bipap avaps cseries device was not operating properly and the patient expired.The reporter of the event confirms the patient's family is not releasing the device.The device is not returning for evaluation.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: BIPAP AVAPS CSERIES
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS RESPIRONICS INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): PHILIPS RESPIRONICS INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: adam price ; 1001 murry ridge lane; murrysville, PA 15668
• MDR Report Key: 12009571
• MDR Text Key: 256506619
• Report Number: 2518422-2021-01718
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959015777
• UDI-Public: 00606959015777
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CN1167HS
• Device Catalogue Number: CN1167HS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death