MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 05/28/2022

Event Type  malfunction  

Event Description

Called to patients¿ room by nurse due to bipap alarming expiratory occlusion.Found bipap alarming rotary expiratory occlusion.Removed bipap from patient.Patient placed on nasal cannula.No pressure noted from machine.Bipap pulled and patient placed on new machine.

• Brand Name: BIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 14955638
• MDR Text Key: 295485026
• Report Number: 14955638
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2022
• Device Age: 75 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Sex: Male