FDA Adverse Event Malfunction Summary report: N

PROMETRA PATIENT THERAPY CONTROLLER

MDR report key: 6125399 · Received November 23, 2016

Report

Report Number: 3006803715-2016-00182
Event Type: Malfunction
Date Received: November 23, 2016
Date of Event: October 24, 2016
Report Date: October 24, 2016
Manufacturer: FLOWONIX MEDICAL, INC
Product Code: LKK
UDI-DI: 00810335020174
PMA / PMN Number: P080012
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: THE DEVICE WAS SUBJECTED TO VISUAL INSPECTION, AS WELL AS FUNCTIONAL AND ELECTRICAL TESTING. THE EVALUATION DETERMINED THAT THE ISSUE WAS DUE TO THE BATTERY DISCHARGING PAST THE INTERNAL THRESHOLD LIMIT. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED EVENT WAS CONFIRMED. (B)(4).

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: THE DEVICE WAS SUBJECTED TO VISUAL INSPECTION, AS WELL AS FUNCTIONAL AND ELECTRICAL TESTING. THE EVALUATION DETERMINED THAT A COMPONENT WOULD NOT TURN BACK ON AFTER A FULL BATTERY DISCHARGE. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED EVENT WAS CONFIRMED. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT THERAPY CONTROLLER (PTC) COULD NOT BE POWERED ON, BUT DISPLAYED THAT IT WAS FULLY CHARGED WHEN CONNECTED TO THE CHARGER. THE DEVICE WAS RETURNED FOR EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
776680	PROMETRA PATIENT THERAPY CONTROLLER	INFUSION PUMP PROGRAMMER	LKK	FLOWONIX MEDICAL, INC	12860		00810335020174

Patients

Seq	Age	Sex	Outcome	Treatment
1