Device product
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)
Z-2032-2023
Product summary
- Event
- Event 92455
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 2707 units
- Official record key
device-enforcement:Z-2032-2023
Official wording
Reason: There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Code information: GTIN 00840682103428
Distribution pattern: Worldwide
Derived failure modes
-
Unknown
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.