FDA Adverse Event
Malfunction
Summary report: N
VENTAB HYPERINFLATION SYSTEM
MDR report key: 2321631
·
Received October 19, 2011
Report
- Report Number
- 2246980-2011-00005
- Event Type
- Malfunction
- Date Received
- October 19, 2011
- Date of Event
- August 12, 2011
- Report Date
- October 19, 2011
- Manufacturer
- VENTLAB CORPORATION
- Product Code
- NHK
- PMA / PMN Number
- K013308
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL. THE USER-FACILITY PROVIDED A PHOTOGRAPH OF THE DEVICE AND BY EXAMINATION OF THIS PHOTO THE O2 PORT WAS BROKEN OFF. IT IS UNK AND INCONCLUSIVE AS TO HOW THE O2 PORT BROKE OFF. THE RETURN OF THE ACTUAL DEVICE WOULD BE REQUIRED FOR A COMPLETE EVAL AND THE USER-FACILITY WOULD NOT RELEASE THE DEVICE TO US.
Description of Event or Problem · 1
CHILD CODING - THE O2 CONNECTION TO VALVE BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENTAB HYPERINFLATION SYSTEM | HYPERINFLATION SYSTEM | NHK | VENTLAB CORPORATION | HS4151 | 95476 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |