FDA Adverse Event
Malfunction
Summary report: N
1ST RESPONSE RESUSCITATOR, INFANT
MDR report key: 1053503
·
Received May 28, 2008
Report
- Report Number
- 1217052-2008-00074
- Event Type
- Malfunction
- Date Received
- May 28, 2008
- Date of Event
- April 25, 2008
- Report Date
- April 25, 2008
- Manufacturer
- SMITHS MEDICAL ASD, INC. BY: GALEMED CORPORATION
- Product Code
- BTM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SMITHS MEDICAL WAS NOTIFIED OF THE EVENT ON APRIL 25, 2008. HOWEVER, NOT UNTIL WE RECEIVED THE SAMPLES ON MAY 27TH, WAS THE DETERMINATION MADE THAT THIS WOULD BE A REPORTABLE EVENT. THE SAMPLES HAVE BEEN FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. UPON RECEIPT OF THE COMPLETED INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. WE CAN REPORT THAT WE HAVE NOT RECEIVED ANY OTHER REPORTS ON THIS DEVICE LOT NUMBER.
Description of Event or Problem · 1
USER ALLEGES HAVING SEVERAL EVENTS WHERE THE MASKS WERE UNDERINFLATED. NO INJURIES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1ST RESPONSE RESUSCITATOR, INFANT | 73 BTM - RESUSCITATOR, PULMONARY, MANUALLY-OPERATED, SINGLE-USE | BTM | SMITHS MEDICAL ASD, INC. BY: GALEMED CORPORATION | 070314 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |