MAUDE Adverse Event Report: NIHON KOHDEN TOMIOKA CORPORATION ZM-541PA; TRANSMITTER

Model Number ZM-541PA

Device Problems Premature Discharge of Battery (1057); Electrical /Electronic Property Problem (1198); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/23/2015

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the transmitter battery contacts will not hold a battery.The bme states the nurse mentioned the transmitter smoked when putting in the battery.The bme also states the negative contact appears to be missing.The device was not in use on a patient.The device has been returned to nihon kohden but it has not yet been evaluated.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 battery contacts will not hold a battery.The bme states the nurse mentioned the transmitter smoked when putting in the battery.The bme also states the negative contact appears to be missing.The device was not in use on a patient.

• Brand Name: ZM-541PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 486 nanokaichi; tomioka city, japan 370-2 343; JA 370-2343
• Manufacturer (Section G): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; tokyo, japan 161-8 560; JA 161-8560
• Manufacturer Contact: thomas bento ; 1-31-4 nishiochia, shinjuku-ku; tokyo, japan 161-8-560 ; JA 161-8560 ; 2687708
• MDR Report Key: 5365641
• MDR Text Key: 36234835
• Report Number: 8030229-2016-00016
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/13/2016,12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-541PA
• Device Catalogue Number: ZM-541PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2016
• Distributor Facility Aware Date: 12/23/2015
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2016
• Initial Date Manufacturer Received: 01/13/2016
• Initial Date FDA Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1