FDA Adverse Event
Malfunction
Summary report: N
Z-800 INFUSION SYSTEM
MDR report key: 19806896
·
Received July 23, 2024
Report
- Report Number
- 3006575795-2024-00521
- Event Type
- Malfunction
- Date Received
- July 23, 2024
- Date of Event
- July 3, 2024
- Report Date
- July 23, 2024
- Manufacturer
- ZYNO MEDICAL LLC
- Product Code
- FRN
- UDI-DI
- 00814371020013
- PMA / PMN Number
- K130690
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A CAPA HAS BEEN OPENED TO INVESTIGATE THIS FAILURE MODE.
Description of Event or Problem · 0
ON 07/03/2024, ZYNO MEDICAL LLC RECEIVED A REPORT THAT THE DEVICE WAS REPORTED TO HAVE A FLOWRATE OFFSET OF -03%.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 964926 | Z-800 INFUSION SYSTEM | LARGE VOLUME INFUSION PUMP | FRN | ZYNO MEDICAL LLC | Z800F | 200716968 | 00814371020013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |