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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN TOMIOKA CORPORATION ZM-531PA; TRANSMITTER
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NIHON KOHDEN TOMIOKA CORPORATION ZM-531PA; TRANSMITTER Back to Search Results
Model Number ZM-531PA
Device Problems Overheating of Device (1437); Temperature Problem (3022)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/04/2016
Event Type  malfunction  
Manufacturer Narrative
The customer reported that a nurse noticed a transmitter was getting very hot on a patient.Patient was not harmed and is stable.The biomedical engineer received the transmitter within minutes of the nurse discovering the hot unit.The biomedical engineer tested the unit and confirmed it still worked.In the process he found what had caused the transmitter to get very hot.He advised the batteries had started to come apart and leak, this started melting the transmitter battery bay.The hospital is writing up an event for this complaint.Nihon kohden sent the customer an exchange and instructed the biomedical engineer to send in his unit once the hospital is complete with their investigation.The hospital will include their documents on the complaint with the damaged unit they are sending back.The customer device has not yet been received.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 a nurse noticed a transmitter was getting very hot on a patient.Patient was not harmed and is stable.
 
Manufacturer Narrative
The customer reported that a nurse noticed a transmitter was getting very hot on a patient.Patient was not harmed and is stable.The biomedical engineer received the transmitter within minutes of the nurse discovering the hot unit.The biomedical engineer tested the unit and confirmed it still worked.In the process he found what had caused the transmitter to get very hot.He advised the batteries had started to come apart and leak, this started melting the transmitter battery bay.The hospital is writing up an event for this complaint.Nihon kohden sent the customer an exchange and instructed the biomedical engineer to send in his unit once the hospital is complete with their investigation.The hospital will include their documents on the complaint with the damaged unit they are sending back.On 07/26/2016 nihon kohden followed up with the customer.The customer states they are going to send the device and batteries as well as their incident report.The customer device has not yet been received.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.
 
Manufacturer Narrative
The customer reported that the transmitter stopped transmitting data.When the staff went to check on the patient it was noted that the transmitter was getting very hot on a patient.Patient was not harmed and is stable.The biomedical engineer received the transmitter within minutes of the nurse discovering the hot unit.The biomedical engineer tested the unit and confirmed it still worked.In the process he found what had caused the transmitter to get very hot.He advised the batteries had started to come apart and leak, this started melting the transmitter battery bay.The hospital is writing up an event for this complaint.Nihon kohden sent the customer an exchange and instructed the biomedical engineer to send in his unit once the hospital is complete with their investigation.The hospital will include their documents on the complaint with the damaged unit they are sending back.On (b)(6) 2016 nihon kohden followed up with the customer.The customer states they are going to send the device and batteries as well as their incident report.As of (b)(6) 2016 the customer device has not yet been received at nihon kohden america.The device was received by nihon kohden on (b)(6) 2016 and evaluated.It was confirmed that the battery compartment casing was melted and deformed.Additionally, the spring in the battery compartment was bent upward and the battery was leaking.The conclusion of the investigation is that the bent spring was caused by the customer incorrectly inserting the batteries into the device.This caused the spring to rupture the battery label jacket.When the label jacket ruptured, the positive electrode (outer casing) contacted the negative electrode via the spring, which produced a short circuit.A large current in the spring created excessively high temperatures and disrupted monitoring of the device.The high temperature caused the battery compartment to melt, deform, and leak as observed in the device and batteries provided to nihon kohden by the customer.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if any additional information becomes available.
 
Event Description
The customer reported that the transmitter stopped transmitting data.When the staff went to check on the patient it was noted that the transmitter was getting very hot on a patient.Patient was not harmed and is stable.
 
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Brand Name
ZM-531PA
Type of Device
TRANSMITTER
Manufacturer (Section D)
NIHON KOHDEN TOMIOKA CORPORATION
1-1 tajino
attn: susan shadley
tomioka city, japan 370-2 314
JA  370-2314
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
1-1 tajino
attn: susan shadley
tomioka city, japan 370-2 314
JA   370-2314
Manufacturer Contact
susan shadley
1-31-4 nishiochiai, shinjuku-k
attn: susan shadley
tokyo, japan 161-8-560
JA   161-8560
2687133
MDR Report Key5543487
MDR Text Key42074120
Report Number8030229-2016-00144
Device Sequence Number1
Product Code DRG
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,Followup
Report Date 04/03/2016,03/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberZM-531PA
Device Catalogue NumberZM-531PA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/03/2016
Distributor Facility Aware Date03/04/2016
Device Age25 MO
Event Location Hospital
Date Report to Manufacturer04/03/2016
Date Manufacturer Received04/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2014
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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