Device product
The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.
Z-1203-2017
Product summary
- Event
- Event 75616
- Status
- Terminated
- Classification
- Class II
- Quantity
- 341 sites potentially have the affected product versions
- Official record key
device-enforcement:Z-1203-2017
Official wording
Reason: Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure.
Code information: Patient Data Module (PDM) V2 model: Serial numbers 10.03.XXXXX
Distribution pattern: Distribution was nationwide to medical facilities. There was also military and government distribution.
Derived failure modes
-
Unknown
Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure.