FDA Adverse Event Malfunction Summary report: N

CARDIONET MONITOR

MDR report key: 1323519 · Received February 22, 2009

Report

Report Number
MW5010050
Event Type
Malfunction
Date Received
February 22, 2009
Date of Event
February 20, 2009
Report Date
February 22, 2009
Manufacturer
CARDIONET, INC.
Product Code
DSI
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

MONITOR BATTERY FAILED TO HOLD A CHARGE, GIVING A 'LOW BATTERY' SIGNAL TO USER; TIME PERIOD IS APPROX 9 HOURS. IN 2009, I LEFT FOR WORK CIRCA 8 AM AND TOOK MONITOR WITH ME AS PER USE INSTRUCTIONS. CIRCA 5 PM, MONITOR BEGAN BEEPING WITH A 'LOW BATTERY' MESSAGE. THE MONITOR HAD BEEN IN ITS CHARGING, DOCKING STATION ALL NIGHT [CIRCA 11 PM TO CIRCA 7 AM IN THE MORNING]. THE NEXT DAY, I AGAIN LEFT THE HOUSE WITH THE MONITOR WITH IT FULLY CHARGED. UPON RETURN TO MY HOME AT CIRCA 1 PM, MONITOR BATTERY SHOWED ONLY A 43% CHARGE REMAINING. I CALLED THE CARDIONET STAFF, AND THEY KINDLY ARRANGED TO HAVE A 2ND 15 VOLT ADAPTER SENT TO ME, SO I CAN PLUG THE MONITOR IN AT MY OFFICE AS A WORKAROUND. THIS IS NOT A MEDICAL EMERGENCY; IT IS A NUISANCE TO HAVE TO CHARGE THIS UNIT DURING THE DAY WHILE I AM AT WORK. THE 15 VOLT SYSTEM DOES NOT ALLOW ONE TO BE MOBILE IN YOUR CAR [12 VOLTS] DURING THE DAY. THE ROOT CAUSE MAY BE, BAD ELECTRICAL SUPPLY AT MY HOME [USED TWO DIFFERENT WALL SOCKETS AND UPGRADED ELECTRICAL PANEL IN HOUSE IN 2002], A BAD 15 VOLT ADAPTER, OR A BAD BATTERY IN THE DEVICE. IF THIS IS PANDEMIC WITH THESE DEVICES, THEN MANUFACTURER SHOULD REDESIGN THE BATTERY SPEC AND DO SOME 'IN LIFE' USE TESTING FOR FOLKS LIKE ME WHO WORK ALL DAY, GO TO A FITNESS CENTER AFTER WORK, BEFORE GOING HOME [ABOUT A 10-11 HOUR TIME INTERVAL]. THE BATTERY IN THIS DEVICE CANNOT AND DOES NOT LAST THAT LONG. DOSE OR AMOUNT: NA. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: ATRIAL FIBRILLATION. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CARDIONET MONITOR NONE DSI CARDIONET, INC. AECG TYPE 1 G69794

Patients

Seq Age Sex Outcome Treatment
1 62 YR Other