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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 Problem Device Alarm System (1012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/14/2019
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the central nurse's station (cns) is not alarming v-tach and the org multiple patient receiver provides the signal analysis from the transmitter. This is a use error issue as the appropriate leads were not used for arrythmia analysis and the recommendation was to use multi-read analysis or change trace 1 to ii lead and do single-read analysis. This is not a device failure. Nkc investigation: in single-lead analysis, some qrs complexes were not detected due to low amplitude, and the remaining qrs-detected beats were judged as the v-tach alarm did not occur. The average heart rate decreased slightly to about 72 bpm, but it did not alarm because bradycardia was set to 50 bpm or less. Therefore, it is determined that the v-tach alarm did not occur because trace 1 has low amplitude. Recommendation: use multi-read analysis or change trace 1 to ii lead and do single-read analysis.
 
Event Description
The customer reported that the central nurse's station (cns) is not alarming v-tach and the org multiple patient receiver provides the signal analysis from the transmitter.
 
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Brand NameORG-9110A
Type of DeviceMULTIPLE 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, 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 Key8614167
MDR Text Key145241962
Report Number8030229-2019-00154
Device Sequence Number1
Product Code DRG
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 07/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORG-9110A
Device Catalogue NumberORG-9110A
Device Lot NumberNOT APPLICABLE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/25/2019
Distributor Facility Aware Date07/24/2019
Event Location Hospital
Date Report to Manufacturer07/25/2019
Date Manufacturer Received07/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberNOT APPLICABLE

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