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U.S. Department of Health and Human Services

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

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NIHON KOHDEN CORPORATION ZM-541PA; TRANSMITTER Back to Search Results
Model Number ZM-541PA
Device Problems Thermal Decomposition of Device (1071); Melted (1385); Overheating of Device (1437); Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/27/2016
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the transmitter overheated and the battery contacts melted.There is no other physical damage and no fluid intrusion.The device was returned to nihon kohden, evaluated, and the reported issue was confirmed.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 overheated and the battery contacts melted.There is no other physical damage and no fluid intrusion.
 
Manufacturer Narrative
The customer reported that the transmitter overheated and the battery contacts melted.There is no other physical damage and no fluid intrusion.The unit was cleaned and evaluated.The reported problem of the battery contacts are melted was duplicated.All malfunctioning parts have been replaced.The unit was tested per the operator's manual and the results were recorded on the maintenance check sheet.The unit completed one day of extended testing and operates to manufacture's specifications.Top case was damaged apparently caused by customer installed battery contact r improperly.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.
 
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Brand Name
ZM-541PA
Type of Device
TRANSMITTER
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
attn: shama mooman
tokyo, japan 161-8 560
JA  161-8560
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
1-1 tajino
attn: shama mooman
gunma 370-2 314
JA   370-2314
Manufacturer Contact
shama mooman
safety mgmt dept, quality mgmt
seibu bldg 2, 4th floor 1-11-2
kusunokidai tokorozawa, saitama 359-8-580
JA   359-8580
2687488
MDR Report Key5828409
MDR Text Key51279174
Report Number8030229-2016-00362
Device Sequence Number1
Product Code DRT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043517
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 07/27/2016,06/27/2016
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 NumberZM-541PA
Device Catalogue NumberZM-541PA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/27/2016
Distributor Facility Aware Date06/27/2016
Device Age13 MO
Event Location Hospital
Date Report to Manufacturer07/27/2016
Initial Date Manufacturer Received 07/27/2016
Initial Date FDA Received07/27/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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