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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN TOMIOKA CORPORATION ZM-541PA; TRANSMITTER
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NIHON KOHDEN TOMIOKA CORPORATION ZM-541PA; TRANSMITTER Back to Search Results
Model Number ZM-541PA
Device Problems Device Inoperable (1663); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/16/2015
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the transmitter inflates and just stays full but never takes a pressure.The customer has replaced the cuff and batteries and the issue stays the same.Customer stated it inflates to 180 and just stays and never times out.The device was returned to nihon kohden, evaluated, and the reported issue was confirmed.When the transmitter was received and examined it was noted that the transmitter had evidence of fluid intrusion and was contaminated.The unit was properly disposed of in nihon kohden's biohazard location.Customer was provided with a transmitter exchange.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.
 
Event Description
The customer reported that the transmitter inflates and just stays full but never takes a pressure.The customer has replaced the cuff and batteries and the issue stays the same.Customer stated it inflates to 180 and just stays and never times out.
 
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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 Key5305104
MDR Text Key33701535
Report Number8030229-2015-00444
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
Report Date 12/16/2015,11/16/2015
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 NumberZM-541PA
Device Catalogue NumberZM-541PA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/16/2015
Distributor Facility Aware Date11/16/2015
Device Age34 MO
Event Location Hospital
Date Report to Manufacturer12/16/2015
Initial Date Manufacturer Received 12/16/2015
Initial Date FDA Received12/16/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2013
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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