FDA Adverse Event
Malfunction
Summary report: N
ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
MDR report key: 18974958
·
Received March 25, 2024
Report
- Report Number
- 3006575795-2024-00068
- Event Type
- Malfunction
- Date Received
- March 25, 2024
- Date of Event
- March 11, 2024
- Report Date
- March 25, 2024
- Manufacturer
- ZYNO MEDICAL, LLC
- Product Code
- FRN
- UDI-DI
- 00814371020037
- PMA / PMN Number
- K130690
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
ON 3/11/2024, CCLUSION ISSUE WAS OBSERVED AT ZYNO MEDICAL LLC DURING CALIBRATION. ISSUE TRACED TO MAINTENANCE AS THERE WERE NO PM'S DONE DURING 2023.
Description of Event or Problem · 0
ON 03/11/2024, DURING SERVICING ACTIVITIES OF ZYNO MEDICAL DEVICES, THERE WAS AN ISSUE OBSERVED DURING PREVENTIVE MAINTENACE/ CALIBRATION THAT THERE IS OCCLUSION ERROR WHERE 30 PSI VALUE AT PRE-REWORK IS 293 AND POST-REWORK IS 278 B.F. THIS IS DETERMINED TO BE A OCCLUSION SENSOR MODULE UNKNOWN ISSUE. NO PATIENT INVOLVED AS THIS IS OBSERVED DURING CALIBRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 943 | ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM | LARGE VOLUME INFUSION PUMP | FRN | ZYNO MEDICAL, LLC | Z800WF | 191105292 | 00814371020037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |