BIPAP AUTO SERIES
Report
- Report Number
- 2518422-2022-09447
- Event Type
- Malfunction
- Date Received
- March 9, 2022
- Date of Event
- September 25, 2019
- Report Date
- April 18, 2022
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- BZD
- UDI-DI
- 00606959031524
- PMA / PMN Number
- K050759
- Removal / Correction Number
- RES 88058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- 003
Narratives
THIS MDR IS BEING SUBMITTED AS PART OF A BATCH SUBMISSION OF COMPLAINTS THAT WERE REASSESSED AS REPORTABLE FOAM DEGRADATION COMPLAINTS; DISCOVERED AS PART OF A RETROSPECTIVE REMEDIATION REVIEW.
THE MANUFACTURER PREVIOUSLY REPORTED THAT REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE, OCCURED IN SECTION B2. AFTER REVIEW, IT WAS DETERMINED THAT THIS OPTION WAS INCORRECTLY SELECTED IN SECTION B2. NOTHING SUCH HAS OCCURED TO THE PATIENT. THE REPORT SHOULD HAVE BEEN SENT FOR PRODUCT PROBLEM ONLY IN SECTION B1. IN G4 SECTION PMA/510(K) NUMBER WAS INCORRECT THE CORRECT VALUE IS K050759. AND E1, D1 ARE UPDATED. IN D4 NO UDI NUMBER WAS PRESENT.
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE MANUFACTURER RECEIVED INFORMATION ALLEGING BLACK PARTICLES IN BIPAP DEVICE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2539102 | BIPAP AUTO SERIES | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | RESPIRONICS, INC. | 751P | 00606959031524 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |