FDA Adverse Event
Malfunction
Summary report: N
Z-800 INFUSION PUMP
MDR report key: 2082188
·
Received April 29, 2011
Report
- Report Number
- 3006575795-2011-00008
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- January 27, 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
- MA, 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 DEVICE IS IN NEED OF REPAIR AND RE-CALIBRATION. THE PUMP WAS REPAIRED, RE-CALIBRATED AND TESTED PER SPECIFICATIONS.
Description of Event or Problem · 1
THE DEVICE DISTRIBUTOR REPORTED THAT THE PUMP WOULD NOT OCCLUDE AND HAD A CONSTANT "BATTERY LOW" ALARM. THERE WAS NO PATIENT INVOLVED. ZYNO MEDICAL LLC HAS REQUESTED BUT HAS NOT RECEIVED ANY 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 | 20090126 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |