Device product
O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients
Z-2705-2017
Product summary
- Event
- Event 77528
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4382 units (4082 units distributed USA)
- Official record key
device-enforcement:Z-2705-2017
Official wording
Reason: Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning device was reported to be twice that of the rate noted on the label.
Code information: Lot #s: 079810; 078734, 081071, 140411, 141117, 140719, 140506, 130117 Expiration date: Jul.2016
Distribution pattern: Worldwide Distribution - US (nationwide) Canada, Europe Denmark and Finland
Derived failure modes
-
Unknown
Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning device was reported to be twice that of the rate noted on the label.