FDA Adverse Event
Injury
Summary report: N
HIR-200
MDR report key: 460205
·
Received May 14, 2003
Report
- Report Number
- 1221261-2003-00032
- Event Type
- Injury
- Date Received
- May 14, 2003
- Date of Event
- April 12, 2003
- Report Date
- May 13, 2003
- Manufacturer
- LEVEL 1, INC.
- Product Code
- KZD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PRESSURE CHAMBER DOOR BLEW APART AND A PIECE OF THE CHAMBER HIT A NURSE. NO INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIR-200 | PRESSURE INFUSER | KZD | LEVEL 1, INC. | HIR-200 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |