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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 Problem Protective Measures Problem (3015)
Patient Problem Unspecified Heart Problem (4454)
Event Date 06/28/2021
Event Type  malfunction  
Manufacturer Narrative
The customer reported that their transmitter gave them a false reading of asystole after which their staff panicked and gave their patient medication to prevent an insinuated heart attack.They also said that the patient is fine but the staff had to go through these steps unnecessarily due to the false readings.
 
Event Description
The customer reported that their transmitter gave them a false reading of asystole after which their staff panicked and gave their patient medication to prevent an insinuated heart attack.They also said that the patient is fine but the staff had to go through these steps unnecessarily due to the false readings.
 
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Brand Name
ZM-541PA
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 Key12236653
MDR Text Key269586131
Report Number2080783-2021-01431
Device Sequence Number1
Product Code DRT
UDI-Device Identifier04931921106617
UDI-Public04931921106617
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/27/2021
Distributor Facility Aware Date06/28/2021
Device Age116 MO
Event Location Hospital
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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