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

Model Number 1060P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/26/2019

Event Type  Injury  

Event Description

The manufacturer received information alleging a bipap s/t c series humidifier was not working properly.The patient had a nose bleed that required hospitalization and a blood transfusion.The device has yet to be returned to the manufacturer for evaluation.A follow up report will be filed when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported a bipap s/t c series humidifier was allegedly not working properly.The patient had a nose bleed that required hospitalization and a blood transfusion.Repeated attempts to have the device returned for evaluation and investigation were unsuccessful.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 S/T CSERIES
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS RESPIRONICS INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 9682224
• MDR Text Key: 178166496
• Report Number: 2518422-2020-00336
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• PMA/PMN Number: K092818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1060P
• Device Catalogue Number: 1060P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR