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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9700A RECEIVER UNIT

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NIHON KOHDEN CORPORATION ORG-9700A RECEIVER UNIT Back to Search Results
Model Number ORG-9700A
Device Problems False Alarm (1013); Improper Alarm (2951)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/04/2016
Event Type  malfunction  
Manufacturer Narrative
The customer reports that alarm occurrences such as vpc, couplet, and, r-r do not match the displayed waveform. The biomedical engineer tried to duplicate the issue, however was unsuccessful. The biomedical engineer stated that the department is disorganized but will try to gather additional data. 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.
 
Event Description
The customer reports that alarm occurrences such as vpc, couplet, and, r-r do not match the displayed waveform. The biomedical engineer tried to duplicate the issue, however was unsuccessful. The biomedical engineer stated that the department is disorganized but will try to gather additional data.
 
Manufacturer Narrative
Manufacturer narrative: the customer reports that alarm occurrences such as vpc, couplet, and, r-r do not match the displayed waveform. The biomedical engineer tried to duplicate the issue, however, was unsuccessful. The biomedical engineer stated that the department is disorganized but will try to gather additional data. The device was never sent in for evaluation. Due to the age of this complaint additional information necessary to conduct an investigation is not readily available. Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803. 56 if additional information becomes available.
 
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Brand NameORG-9700A
Type of DeviceRECEIVER UNIT
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
attn: shama mooman
tokyo, japan 161-8 560
JA 161-8560
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
1-1 tajino
attn: shama mooman
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
2687488
MDR Report Key5482365
MDR Text Key39985330
Report Number8030229-2016-00095
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 03/05/2016,02/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/05/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORG-9700A
Device Catalogue NumberMU-970RA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/05/2016
Distributor Facility Aware Date02/04/2016
Device Age144 MO
Event Location Hospital
Date Report to Manufacturer03/05/2016
Date Manufacturer Received03/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/08/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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