FDA Adverse Event
Malfunction
Summary report: N
HUDSON REUSABLE MANUAL RESUSCITATION BAG/MASK
MDR report key: 2181199
·
Received July 7, 2011
Report
- Report Number
- 1044475-2011-00078
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- June 16, 2011
- Report Date
- June 29, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTM
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: "THE VALVE DOESN'T ATTACH VERY WELL TO THE BAG, IT SEEMS THE O-RING ISN'T SEALING THE CONNECTION VERY WELL. THE VALVE DISCONNECTED EASILY FROM THE BAG." DEFECT WAS DISCOVERED UPON INSPECTION. NO REPORTED PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON REUSABLE MANUAL RESUSCITATION BAG/MASK | RESUSCITATION BAG | BTM | TELEFLEX MEDICAL | NA | 4563414 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |