Device product
DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
Z-0457-2016
Product summary
- Event
- Event 72619
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5 units
- Official record key
device-enforcement:Z-0457-2016
Official wording
Reason: Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.
Code information: SN: 73962222, 73962223, 73962224, 73962225, and 73962226
Distribution pattern: US Nationwide Distribution in the states of South Carolina, Florida, and Canada.
Derived failure modes
-
Unknown
Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.