FDA Adverse Event
Malfunction
Summary report: N
PROMETRA PATIENT THERAPY CONTROLLER
MDR report key: 6028355
·
Received October 13, 2016
Report
- Report Number
- 3006803715-2016-00157
- Event Type
- Malfunction
- Date Received
- October 13, 2016
- Date of Event
- September 13, 2016
- Report Date
- September 14, 2016
- Manufacturer
- FLOWONIX MEDICAL, INC
- Product Code
- LKK
- PMA / PMN Number
- P080012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE DEVICE WAS SUBJECTED TO VISUAL EXTERNAL AND INTERNAL INSPECTION AND FUNCTIONAL TESTING. THE EVALUATION DETERMINED THAT THE ISSUE WAS DUE TO A DAMAGED MICRO-USB PORT. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED EVENT WAS CONFIRMED. (B)(4).
Additional Manufacturer Narrative · 1
INTERNAL COMPLAINT NUMBER: (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT THERAPY CONTROLLER (PTC) SERIAL NUMBER WAS WORN AWAY, AND THE DEVICE COULD NOT BE CHARGED. THE DEVICE DID NOT RESPOND TO BEING CONNECTED TO A CHARGER, AND TROUBLESHOOTING ATTEMPTS WERE NOT SUCCESSFUL. THERE WERE NO PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 676829 | PROMETRA PATIENT THERAPY CONTROLLER | INFUSION PUMP PROGRAMMER | LKK | FLOWONIX MEDICAL, INC | 12860 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |