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

Model Number 1111169

Device Problem Degraded (1153)

Patient Problem Inflammation (1932)

Event Date 07/26/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging that a bilevel positive airway pressure (bipap) device's sound abatement foam became degraded and caused the patient to experience upper nasal issues marked by intensive antibiotic therapy and an admission into the intensive care unit (icu).This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

Corrected data: e1 initial reporter name and address: previously reported as (b)(6) ; updated to (b)(6).(b)(6) g3 date received by manufacturer: previously reported as 21-sep-2021 ; updated to 14-sep-2021.

• Brand Name: BIPAP A40
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• MDR Report Key: 12540679
• MDR Text Key: 273585889
• Report Number: 2518422-2021-04477
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00606959039476
• UDI-Public: 00606959039476
• Combination Product (y/n): N
• PMA/PMN Number: K121623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

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: 1111169
• Device Catalogue Number: 1111169
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 09/28/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 09/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2019
• 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): Hospitalization