FDA Adverse Event
Death
Summary report: N
1ST RESPONSE RESUSCITATOR, ADULT
MDR report key: 545294
·
Received September 22, 2004
Report
- Report Number
- 1217052-2004-00073
- Event Type
- Death
- Date Received
- September 22, 2004
- Date of Event
- August 1, 2004
- Report Date
- August 23, 2004
- Manufacturer
- SMITHS MEDICAL ASD, INC./GALEMED CORPORATION
- Product Code
- BTM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
USER ALLEGES THAT A RESUSCITATOR WAS USED DURING A CODE SITUATION. AFTER THE SECOND SQUEEZE OF THE RESUSCITATOR THE MASK DEFLATED. ANOTHER UNIT WAS OBTAINED AND THE SAME THING OCCURRED. HOSPITAL STATED THAT THEY DO NOT KNOW IF PT OUTCOME WAS DUE TO THIS ISSUE OR DUE TO PT CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1ST RESPONSE RESUSCITATOR, ADULT | MANUAL RESUSCITATOR SYSTEM | BTM | SMITHS MEDICAL ASD, INC./GALEMED CORPORATION | NA | 030505 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Death |