FDA Adverse Event
Malfunction
Summary report: N
REMSTAR AUTO A-FLE
MDR report key: 16982295
·
Received May 23, 2023
Report
- Report Number
- 2518422-2023-11435
- Event Type
- Malfunction
- Date Received
- May 23, 2023
- Date of Event
- April 28, 2023
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- BZD
- UDI-DI
- 00606959005884
- PMA / PMN Number
- K131982
- Removal / Correction Number
- RES 88058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
H3 OTHER TEXT : DEVICE NOT RETUNED TO MANUFACTURER.
Description of Event or Problem · 0
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES IN THE AIR PATH. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1410788 | REMSTAR AUTO A-FLE | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | RESPIRONICS, INC. | DS560S | 00606959005884 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |