Device product
Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
Z-0749-2013
Product summary
- Event
- Event 63761
- Status
- Terminated
- Classification
- Class I
- Quantity
- 276 units total, 109 of those nationwide.
- Official record key
device-enforcement:Z-0749-2013
Official wording
Reason: Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
Code information: Model M1139612
Distribution pattern: Worldwide Distribution - Worldwide Distribution - USA including AL, AZ, CA, CO, FL,GA, IA, ID, IL, KY, MA, MD, MI, MN, MO, MS, MT, NC, ND ,NE, NM, NV, NY, OH, OR, PA ,TX, VT, WA, WI and WV; and the countries of Australia, Belgium, Canada, China, France, New Zealand, Poland, Saudi Arabia, Switzerland and United Kingdom.
Derived failure modes
-
Unknown
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.