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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 Problems Device Operational Issue (2914); Device Sensing Problem (2917)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 05/10/2017
Event Type  malfunction  
Manufacturer Narrative
Corrected data: device available for evaluation, device evaluated by manufacturer, additional manufacture narrative. Additional information: reporter name and address, type of report?, type of report: if follow-up, what type?, event problem and evaluation codes. The customer reported that they have been experiencing intermittent signal loss on their multiple patience receiver, org device. Customer tried to resolve the issue by switching out the transmitter as the issue was occurring on a specific transmitter. It was later noticed that the issue was occurring on all transmitters on the org. Additionally, there have been 5 second signal loss issues on the transmitters. Customer tested all other org's and the issue seems to be with the specific org. Customer was sent a loaner org, however she returned the loaner as this issue is still occurring even with the loaner. The biomedical engineer states that this issue is being caused by their old antenna system on these floors. David cole was deployed onsite to evaluate the site's antenna system.
 
Manufacturer Narrative
The customer reported that they have been experiencing intermittent signal loss on their multiple patient receiver, org device. Customer tried to resolve the issue by switching out the transmitter as the issue was occurring on a specific transmitter. It was later noticed that the issue was occurring on all transmitters on the org. Additionally, there have been 5 second signal loss issues on the transmitters. Customer tested all other org's and the issue seems to be with this specific org. Customer was sent a loaner org, however will be returning the loaner as this issue is still occurring even with the loaner. The biomedical engineer states that this issue has been ongoing for months and has been affecting the 2nd and 3rd floors at the hospital. He believes this issue is being caused by their old antenna system on these floors. They recently completed a new install telemetry expansion and this new install with the new antenna system has had no issues. The customer would like to send the device in for evaluation so they now what steps to take next. 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 reported that they have been experiencing intermittent signal loss on their multiple patient receiver, org device.
 
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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, japan 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
2687488
MDR Report Key6616494
MDR Text Key257719261
Report Number8030229-2017-00167
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 06/06/2017,05/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/06/2017
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? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Report Sent to FDA06/06/2017
Distributor Facility Aware Date05/10/2017
Device Age20 MO
Event Location Hospital
Date Report to Manufacturer06/06/2017
Date Manufacturer Received06/06/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/01/2009
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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