FDA Adverse Event
Malfunction
Summary report: N
HUDSON CIRCUIT, PEDIATRIC, HEATED WIRE DUAL LIMB
MDR report key: 2211935
·
Received August 10, 2011
Report
- Report Number
- 3004365956-2011-00319
- Event Type
- Malfunction
- Date Received
- August 10, 2011
- Date of Event
- July 20, 2011
- Report Date
- August 2, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- CAI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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 THAT THE CIRCUITS HAD VISIBLE CRACKS IN THE CUFF. ALLEGED DEFECT WAS FOUND UPON INSPECTION AND DURING VENT SET-UP. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON CIRCUIT, PEDIATRIC, HEATED WIRE DUAL LIMB | PEDIATRIC VENTILATOR CIRCUIT | CAI | TELEFLEX MEDICAL | NA | 02K1001257 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |