FDA Adverse Event
Malfunction
Summary report: N
K131982
MDR report key: 18767704
·
Received February 23, 2024
Report
- Report Number
- 2518422-2024-09406
- Event Type
- Malfunction
- Date Received
- February 23, 2024
- Date of Event
- February 6, 2024
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- BZD
- PMA / PMN Number
- K131982
- Removal / Correction Number
- Z-1974-2021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
H3 OTHER TEXT : DEVICE NOT YET RETURNED TO THE 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 PATIENT ALLEGES BLACK PARTICLES BLOWING FROM DEVICE AND DEVICE MAKING NOISE DURING OPERATION. THERE WAS NO ALLEGATION OF PATIENT HARM OR INJURY. 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 |
|---|---|---|---|---|---|---|---|
| 259755 | K131982 | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | RESPIRONICS, INC. | DSX500T11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |