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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN TOMIOKA CORPORATION ZM-921PA

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NIHON KOHDEN TOMIOKA CORPORATION ZM-921PA Back to Search Results
Model Number ZM-921PA
Device Problem Thermal Decomposition of Device (1071)
Patient Problem Burn(s) (1757)
Event Date 01/17/2017
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the transmitter's battery got hot and melted the case. The device was in use on a patient and the patient received a minor injury. The staff placed a cold compress on the patient. When the patient was rechecked, the minor injury appeared to resolve. The skin was flesh toned and intact. No blistering or other issues were identified, and the patient did not require additional medical intervention. The patient was discharged normally and sent home. The device was returned to nihon kohden for evaluation. Nihon kohden sent a replacement device to the customer on (b)(6) 2017. Nihon kohden continues to investigate the reported event. Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803. 56 when additional information becomes available.
 
Event Description
The customer reported that the transmitter's battery got hot and melted the case. The device was in use on a patient and the patient received a minor injury.
 
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Brand NameZM-921PA
Type of DeviceZM-921PA
Manufacturer (Section D)
NIHON KOHDEN TOMIOKA CORPORATION
1-1 tajino
attn: shama mooman
tomioka city, japan 370-2 314
JA 370-2314
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
486 nanokaichi
tomioka city, japan 370-2 343
JA 370-2343
Manufacturer Contact
shama mooman
1-31-4 nishiochiai, shinjuku-k
attn: shama mooman
tokyo, japan 161-8-560
JA   161-8560
2687488
MDR Report Key6324411
MDR Text Key67270561
Report Number8030229-2017-00037
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K945578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/10/2017,01/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberZM-921PA
Device Catalogue NumberZM-921PA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/10/2017
Distributor Facility Aware Date01/17/2017
Device Age77 MO
Event Location Hospital
Date Report to Manufacturer02/10/2017
Date Manufacturer Received02/10/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/17/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/10/2017 Patient Sequence Number: 1
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