FDA Adverse Event
Malfunction
Summary report: N
PNEUPAC VENTIPAC WITH ALARMS
MDR report key: 1381616
·
Received March 17, 2009
Report
- Report Number
- 2182466-2009-00005
- Event Type
- Malfunction
- Date Received
- March 17, 2009
- Report Date
- February 17, 2009
- Manufacturer
- SMITHS MEDICAL PM, INC.
- Product Code
- BTL
- PMA / PMN Number
- K030803
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SMITHS MEDICAL PM, INC. KITS A PT CIRCUIT AND REGULATOR AND PACKAGES IT WITH THE VENTILATOR, THEREFORE, SMITHS MEDICAL PM, INC IS REPORTING AS THE MANUFACTURER. THE VENTILATOR WAS RETURNED TO SMITHS MEDICAL PM, INC TECHNICAL SERVICE DEPARTMENT. THE VENTILATOR PASSED ALL FUNCTIONAL TESTING. THE VENTILATOR IS BEING RETURNED TO SMITHS MEDICAL INTERNATIONAL, LTD FOR EVAL.
Description of Event or Problem · 1
CUSTOMER ALLEGES THE VENTILATOR STOPPED CYCLING AFTER 5 MINUTES. PRE-USE CHECKS WERE PERFORMED PRIOR TO ATTACHING THE PT TO THE VENTILATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PNEUPAC VENTIPAC WITH ALARMS | EMERGENCY VENTILATOR | BTL | SMITHS MEDICAL PM, INC. | V200D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |