MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A40; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number 1111171

Device Problem Degraded (1153)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 05/26/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The caregiver alleged a respiratory illness while using the device.Patient also alleged particulates in the circuit.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: BIPAP A40
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• 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 ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 14573155
• MDR Text Key: 293150460
• Report Number: 2518422-2022-28345
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00606959021549
• UDI-Public: 00606959021549
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/02/2022

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: 1111171
• Device Catalogue Number: 1111171
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/29/2022
• Initial Date FDA Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2017
• 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
• Patient Age: 7 YR