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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9100A MULTIPLE PATIENT RECEIVER

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NIHON KOHDEN CORPORATION ORG-9100A MULTIPLE PATIENT RECEIVER Back to Search Results
Model Number ORG-9100A
Device Problem Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2017
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer (bme) reported that two multiple patient receivers (org) power cycled unexpectedly and the telemetry cns showed communication loss. The orgs are connected to a ups along with other org devices. Bme states that the ups has clean power for all of the devices and all of the power outlets being used by all orgs are supported for ups. When the power cycle occurred with the two orgs, the other devices connected to the same ups were not affected. Generator power is also deployed behind the ups for extra backup. They have not had any power outages to his knowledge and the issue was isolated to the org closet. There are 8 orgs in total within the closet. Nihon kohden technical support (nkts) advised the bme to consider connecting one of the orgs to the wall directly and monitor it, as well as trying another upos in place of this one. Nkts asked the customer to double check that all of the power outlets on the ups are in fact clean power from the battery backup and not just pass through ac power. 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 biomedical engineer (bme) reported that two multiple patient receivers (org) power cycled unexpectedly and the telemetry cns showed communication loss.
 
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Brand NameORG-9100A
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, 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 Key7010906
MDR Text Key91466354
Report Number8030229-2017-00392
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
Report Date 11/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORG-9100A
Device Catalogue NumberORG-9100A
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/08/2017
Distributor Facility Aware Date10/11/2017
Device Age95 MO
Event Location Hospital
Date Report to Manufacturer11/08/2017
Date Manufacturer Received11/08/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/26/2010
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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