FDA Adverse Event
Malfunction
Summary report: N
HUDSON NEONATAL DUAL HEATED LIMB CIRCUIT
MDR report key: 1842375
·
Received August 31, 2010
Report
- Report Number
- 3004365956-2010-00220
- Event Type
- Malfunction
- Date Received
- August 31, 2010
- Date of Event
- August 20, 2010
- Report Date
- August 20, 2010
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BZO
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS RETURNED FOR EVAL, HOWEVER, THE RESULTS OF THE EVAL ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE RESPIRATORY SUPERVISOR STATED THAT WHEN SETTING UP THE VENTILATORS FOR THE NICU AND IN DOING THE CIRCUIT PRE-CHECK SHE HAD MULTIPLE CIRCUITS THAT WOULD NOT PASS THE TEST. THE CAP IS CRACKED AT THE WYE. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON NEONATAL DUAL HEATED LIMB CIRCUIT | VENTILATOR CIRCUIT | BZO | TELEFLEX MEDICAL | NA | 02F1002756 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |