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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); Overheating of Device (1437); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/16/2017
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer reported that the transmitter's battery cover was melted and clinicians noticed a burning smell.Upon visual inspection, the biomedical engineer noticed that the battery contacts were also melted.There was no other physical damage or fluid intrusion reported.The device was in use on a patient, however no patient harm was reported.They sent the device in and it is currently awaiting evaluation.The customer was provided with an exchanged transmitter.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.
 
Event Description
The biomedical engineer reported that the transmitter's battery cover was melted and clinicians noticed a burning smell.Upon visual inspection, the biomedical engineer noticed that the battery contacts were also melted.
 
Manufacturer Narrative
Corrected data : device evaluated by manufacturer.Additional information: follow up, additional information/correction, event problem and evaluation codes.The biomedical engineer (bme) reported that the transmitter's battery cover was melted and clinicians notices a burning smell.Upon visual inspection, the bme noticed that the battery contacts were also melted.There was no other physical damage or fluid intrusion reported.The device was in use on a patient, however no patient harm was reported.They set the device in to nihon kohden for evaluation.The customer was provided with an exchanged transmitter.The cause of the transmitter overheating was due to incorrect battery installation.
 
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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, 161-8 560
JA  161-8560
Manufacturer (Section G)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
attn: shama mooman
tokyo, gunma 161-8 560
JA   161-8560
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
MDR Report Key6860464
MDR Text Key86264696
Report Number8030229-2017-00302
Device Sequence Number1
Product Code DRT
UDI-Device Identifier04931921106617
UDI-Public04931921106617
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 09/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2017
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 Manufacturer09/01/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Report Sent to FDA09/12/2017
Distributor Facility Aware Date08/16/2017
Device Age26 MO
Event Location Hospital
Date Report to Manufacturer09/12/2017
Date Manufacturer Received09/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2015
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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