FDA Adverse Event
Injury
Summary report: N
EMERSON
MDR report key: 345897
·
Received August 1, 2001
Report
- Report Number
- 345897
- Event Type
- Injury
- Date Received
- August 1, 2001
- Date of Event
- July 2, 2001
- Report Date
- July 5, 2001
- Manufacturer
- J. H. EMERSON CO.
- Product Code
- JCX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OK, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT WAS VENTILATOR DEPENDENT FOLLOWING AN MVA. THE SUCTION ASPIRATOR FAILED TO PROVIDE SUCTION. THE SWITCH WAS ON WITH THE "ON" INDICATOR LIGHT SHOWING. THE PUMP WAS EXCHANGED AND SENT TO BIOMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 34517 | EMERSON | SUCTION-ASPIRATOR | JCX | J. H. EMERSON CO. | 55JS | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Required Intervention |