FDA Adverse Event
Malfunction
Summary report: N
1ST RESPONSE RESUSCITATOR, INFANT
MDR report key: 658572
·
Received December 27, 2005
Report
- Report Number
- 1217052-2005-00115
- Event Type
- Malfunction
- Date Received
- December 27, 2005
- Date of Event
- December 1, 2005
- Report Date
- December 9, 2005
- Manufacturer
- GALMED CORPORATION, SMITHS MEDICAL ASD
- Product Code
- BTM
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
USER ALLEGES THAT HAD ONE EVENT OF A RESUSCITATOR MISSING THE FACE MASK DURING CODE SITUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1ST RESPONSE RESUSCITATOR, INFANT | MANUAL RESUSCITATOR SYSTEM | BTM | GALMED CORPORATION, SMITHS MEDICAL ASD | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |