FDA Adverse Event
Malfunction
Summary report: N
HUDSON NEONATAL VENTILATOR CIRCUIT, HEATED
MDR report key: 1812488
·
Received August 16, 2010
Report
- Report Number
- 3004365956-2010-00193
- Event Type
- Malfunction
- Date Received
- August 16, 2010
- Date of Event
- August 1, 2010
- Report Date
- August 2, 2010
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- CAI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER FOR EVALUATION, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: WILL NOT PASS VENTILATOR PRESSURE CHECK TEST; CRACK IN THE TEMPERATURE PORT SITE. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON NEONATAL VENTILATOR CIRCUIT, HEATED | VENTILATOR CIRCUIT | CAI | TELEFLEX MEDICAL | NA | 02F1000308 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |