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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-531PA; TRANSMITTER
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NIHON KOHDEN CORPORATION ZM-531PA; TRANSMITTER Back to Search Results
Model Number ZM-531PA
Device Problem Loss of Data (2903)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2021
Event Type  malfunction  
Event Description
The customer reported that the unit drops ecg waveforms.According to the customer, the unit will loose the ecg at the central nurse's station (cns); however, the customer did not have anymore details.There was no patient injury reported.
 
Manufacturer Narrative
The customer reported that the unit drops ecg waveforms.According to the customer, the unit will loose the ecg at the central nurse's station (cns); however, the customer did not have anymore details.There was no patient injury reported.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.
 
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Brand Name
ZM-531PA
Type of Device
TRANSMITTER
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
attn: shama mooman
1-31-4 nishiochia
shinjuku-ku, tokyo 161-8 560
JA  161-8560
MDR Report Key12457489
MDR Text Key280942515
Report Number2080783-2021-01738
Device Sequence Number1
Product Code DRT
UDI-Device Identifier04931921115107
UDI-Public04931921115107
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 09/10/2021
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-531PA
Device Catalogue NumberZM-531PA
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/10/2021
Distributor Facility Aware Date07/27/2021
Device Age53 MO
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CNS
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