FDA Adverse Event
Malfunction
Summary report: N
HUDSON LIFESAVER RESUSCITATION BAG (INFANT)
MDR report key: 2182660
·
Received July 1, 2011
Report
- Report Number
- 1044475-2011-00074
- Event Type
- Malfunction
- Date Received
- July 1, 2011
- Report Date
- June 23, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTM
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE IS AVAILABLE FOR THE MANUFACTURER TO EVALUATE. A FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE CAP FOR THE PRESSURE MANOMETER CONNECTION KEEPS DISLODGING. COMPLAINT STATES THAT THERE WAS A SERIOUS ISSUE WHEN THEY WERE RESUSCITATING A BABY IN THE NICU WHERE THE CAP BECAME DISLODGED AND THEY COULD NOT VENTILATE PROPERLY. NO REPORTED PT INJURY OR INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON LIFESAVER RESUSCITATION BAG (INFANT) | RESUSCITATION BAG | BTM | TELEFLEX MEDICAL | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |