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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9110A; MULTIPLE PATIENT RECEIVER
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NIHON KOHDEN CORPORATION ORG-9110A; MULTIPLE PATIENT RECEIVER Back to Search Results
Model Number ORG-9110A
Device Problems Incorrect Interpretation of Signal (1543); Device Issue (2379); Device Sensing Problem (2917)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/05/2018
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the heart rate numerics and waveforms were showing different values from each other at the cns.The correct reading was the numerics at 55bpm, but the waveform showed 130bpm, which resulted in incorrectly administering medication for a fast heartbeat.No patient harm was reported.Discharging and re-admitting the patient resolved the issue.
 
Event Description
The customer reported that the heart rate numerics and waveforms were showing different values from each other at the cns.The correct reading was the numerics at 55bpm, but the waveform showed 130bpm, which resulted in incorrectly administering medication for a fast heart beat.
 
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Brand Name
ORG-9110A
Type of Device
MULTIPLE PATIENT RECEIVER
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
attn: shama mooman
tokyo, 161-8 560
JA  161-8560
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
1-1 tajino
attn: shama mooman
tomioka city, gunma 370-2 314
JA   370-2314
Manufacturer Contact
shama mooman
safety mgmt dept, quality mgmt
seibu bldg 2, 4th floor 1-11-2
kusunokidai tokorozawa, saitama 359-8-580
JA   359-8580
MDR Report Key7659785
MDR Text Key113075032
Report Number8030229-2018-00245
Device Sequence Number1
Product Code DRG
UDI-Device Identifier04931921103906
UDI-Public04931921103906
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberORG-9110A
Device Catalogue NumberORG-9110A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2018
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/03/2018
Distributor Facility Aware Date06/05/2018
Device Age25 MO
Event Location Hospital
Date Report to Manufacturer07/03/2018
Date Manufacturer Received07/03/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/20/2016
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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