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

Model Number 1061422

Device Problem Degraded (1153)

Patient Problems Apnea (1720); Cancer (3262)

Event Date 10/01/2018

Event Type  Injury  

Event Description

The manufacturer received a voluntary medwatch (mw5107583) in which it was alleged that diagnosed with bladder and prostate cancer, severe central sleep apnea.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: BIPAP ST
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): PHILIPS RESPIRONICS; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 15431181
• MDR Text Key: 300033141
• Report Number: 2518422-2022-81116
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/15/2022

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: 1061422
• Device Catalogue Number: 1061422
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Other