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

Model Number	ZM-921PA
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/17/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.

• Brand Name: ZM-921PA
• Common Device Name: ZM-921PA
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; tomioka city, japan 370-2 314; JA 370-2314
• MDR Report Key: 6324411
• Report Number: 8030229-2017-00037
• Device Sequence Number: 768284
• Product Code: DRG
• UDI-Device Identifier: 04931921106631
• UDI-Public: 04931921106631
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K945578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/17/2017
• Report Date (Section F): 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ZM-921PA
• Device Catalogue Number: ZM-921PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/17/2017
• Device Age: 77 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2017
• Initial Report FDA Received Date: 02/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 02/10/2017