Device product
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF
Z-1183-2024
Product summary
- Firm
- Zyno Medical LLC
- Event
- Event 93857
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 574 units
- Official record key
device-enforcement:Z-1183-2024
Official wording
Reason: When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in therapy and in extreme cases, associated risk of organ failure or death
Code information: UDI: 00814371020037 software version 5.2.05
Distribution pattern: Nationwide
Derived failure modes
-
Device software or design
software version 5.2.05, the alarm volume may