FDA Adverse Event
Injury
Summary report: N
DREAMSTATION ST30 H/HT
MDR report key: 15076510
·
Received July 21, 2022
Report
- Report Number
- 2518422-2022-60180
- Event Type
- Injury
- Date Received
- July 21, 2022
- Date of Event
- July 7, 2022
- Report Date
- July 21, 2022
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- BZD
- PMA / PMN Number
- K102465
- Removal / Correction Number
- RES 88058
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED BLACK SPOTS SCATTERED ON THE LUNGS. THE PATIENT DID NOT REPORT TO RECEIVE MEDICAL INTERVENTION. 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 |
|---|---|---|---|---|---|---|---|
| 263116 | DREAMSTATION ST30 H/HT | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | RESPIRONICS, INC. | CNX1030T17 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |