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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN TELEPACK TELEPACK MONITOR

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NIHON KOHDEN TELEPACK TELEPACK MONITOR Back to Search Results
Model Number ZM531PA
Device Problems Battery (420); Electrode (451); Thermal Decomposition of Device (1071); Failure to Power Up (1476); Smoking (1585); Connection Problem (2900); Material Deformation (2976); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/23/2015
Event Type  Injury  
Event Description

Patient was reading low battery on the nk monitor. Took 2 (b)(6) batteries in telepack, telepack would not turn on. Went to check to see if battery was in wrong position. Batteries were in right but noted one battery to be very hot, barely able to touch to remove with gloves on. Removed those two batteries and placed 2 brand new batteries in telepack, locked the door and telepack turned on. Rhythm noted on monitor. Patient said this is a little warm but not as hot as the last one felt. I said let me just check it, opened the telepack battery in same side was hot again. Placed patient on hardwire to take telepack out of service. Walked out of the room, label on battery started to curl, walked out to nurses' station sat it down. A second later started to smell like an electrical fire, started to slightly smoke, battery wrapper opened up black portion was bulging out of the wrapper. Noted that the negative terminal of the nk pack was bent a gap between the negative terminal and plastic cover exists-the (b)(6) batteries were tested with a non-defective telepack. With effort the batteries could be positioned in a way in which the connector came in contact with the plastic cover and negative battery terminal, melting of the cover occured. Battery used was (b)(6).

 
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Brand NameTELEPACK
Type of DeviceTELEPACK MONITOR
Manufacturer (Section D)
NIHON KOHDEN
15353 barranca parkway
irvine CA 92618
MDR Report Key5195514
MDR Text Key30215509
Report NumberMW5057585
Device Sequence Number0
Product Code DPS
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation NURSE
Type of Report Initial
Report Date 10/28/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/28/2015
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2015
Device MODEL NumberZM531PA
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/28/2015 Patient Sequence Number: 1
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