MAUDE Adverse Event Report: NIHON KOHDEN TELEPACK TELEPACK MONITOR

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).

• Brand Name: TELEPACK
• Type of Device: TELEPACK MONITOR
• Manufacturer (Section D): NIHON KOHDEN; 15353 barranca parkway; irvine CA 92618
• MDR Report Key: 5195514
• MDR Text Key: 30215509
• Report Number: MW5057585
• Device Sequence Number: 0
• Product Code: DPS

Combination Product (Y/N)

• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 10/28/2015
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 10/31/2015
• Device MODEL Number: ZM531PA
• 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