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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-530PA; TRANSMITTER

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NIHON KOHDEN CORPORATION ZM-530PA; TRANSMITTER Back to Search Results
Model Number ZM-530PA
Device Problem Incorrect Measurement (1383)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/14/2019
Event Type  malfunction  
Manufacturer Narrative
It was reported that the transmitter displayed inaccurate readings.No consequence or impact to the patient was reported.Nihon kohden continues to investigate the reported event and will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
 
Event Description
It was reported that the transmitter displayed inaccurate readings.No consequence or impact to the patient was reported.
 
Manufacturer Narrative
It was reported that the transmitter displayed inaccurate readings.The reported product was returned and evaluated.Investigation results: the unit was evaluated by the repair center.The reported issue could not be duplicated.The device was evaluated on an ecg simulator and signal amplitude and waveforms were normal.After 48 hours of "burn-in" signals remained stable.An inspection of the interior of the device show no signs of fluid intrusion.No malfunction found.
 
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Brand Name
ZM-530PA
Type of Device
TRANSMITTER
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
attn: shama mooman
tokyo, 116-8 560
JA  116-8560
MDR Report Key8338028
MDR Text Key136144075
Report Number8030229-2019-00043
Device Sequence Number1
Product Code DRT
UDI-Device Identifier04931921115091
UDI-Public4931921115091
Combination Product (y/n)N
PMA/PMN Number
K043517
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 02/13/2019
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-530PA
Device Catalogue NumberZM-530PA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2019
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/13/2019
Distributor Facility Aware Date01/14/2019
Device Age66 MO
Event Location Hospital
Date Report to Manufacturer02/13/2019
Initial Date Manufacturer Received 01/14/2019
Initial Date FDA Received02/13/2019
Supplement Dates Manufacturer Received01/14/2019
Supplement Dates FDA Received03/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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