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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 Failure to Read Input Signal (1581); Device Displays Incorrect Message (2591)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 05/17/2017
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the multiple patient receiver, org has signal loss on three telemetry devices. The signal strength with power on was 15 and with power off was 4, 6, and 8. A power cycle did not fix the issue. Customer sent in the device for evaluation. The reported problem of "signal loss on 3 tele" was duplicated, and the evaluation done by nihon kohden also found 4 other receivers having a spike on the spo2 waveform display. All malfunctioning parts were replaced. The unit was tested per operator's/service manual and the unit completed 24 hours of extended testing and operates to manufacturer's specifications.
 
Manufacturer Narrative
The customer reported that the multiple patient receiver, org has signal loss on three telemetry devices. The signal strength with power on was 15 and with power off was 4, 6, and 8. A power cycle did not fix the issue. Customer would like to send the device in for evaluation. A loaner device was sent to the customer. 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 the multiple patient receiver, org has signal loss on three telemetry devices.
 
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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, 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 Key6620791
MDR Text Key256817950
Report Number8030229-2017-00177
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 06/07/2017,05/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORG-9110A
Device Catalogue NumberORG-9110A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Report Sent to FDA06/07/2017
Distributor Facility Aware Date05/17/2017
Device Age55 MO
Event Location Hospital
Date Report to Manufacturer06/07/2017
Date Manufacturer Received06/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2012
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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