FDA Adverse Event
Malfunction
Summary report: N
Z-800 INFUSION PUMP
MDR report key: 2082159
·
Received April 29, 2011
Report
- Report Number
- 3006575795-2011-00004
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- January 20, 2011
- Report Date
- April 20, 2011
- Manufacturer
- ZYNO MEDICAL LLC.
- Product Code
- FRN
- PMA / PMN Number
- K100705
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION OF THE RETURNED DEVICE INVOLVED IN THIS REPORT BY A ZYNO REPRESENTATIVE INDICATED THAT THE COMPONENT FAILED. PUMP WAS REPAIRED AND RETURNED TO CUSTOMER.
Description of Event or Problem · 1
THE DEVICE DISTRIBUTOR REPORTED THAT THE PUMP DID NOT ALARM A DOWNSTREAM OCCLUSION. ZYNO HAS REQUESTED BUT THE DISTRIBUTOR HAS YET TO PROVIDE INFORMATION REGARDING TO THE ACTUAL SITUATION. THERE WAS NO PATIENT INVOLVED. ZYNO MEDICAL LLC HAS NO INFORMATION TO DETERMINE IF THE ISSUE WAS IDENTIFIED AT END USER FACILITY OR AT THE DISTRIBUTOR SERVICE SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | Z-800 INFUSION PUMP | LARGE VOLUME PERISTALTIC INFUSION PUMP | FRN | ZYNO MEDICAL LLC. | Z-800 | 20090612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |