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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-9100A
Device Problems Noise, Audible (3273); Wireless Communication Problem (3283)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/27/2016
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the org is showing a noisy signal for 4 of its receivers and causing transmitters to have intermittent signal loss. No patient harm was reported. 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 org is showing a noisy signal for 4 of its receivers and causing transmitters to have intermittent signal loss.
 
Manufacturer Narrative
Manufacturer narrative: the customer reported that the org is showing a noisy signal for 4 of its receivers and causing transmitters to have intermittent signal loss. No patient harm was reported. The unit has been evaluated and the customer's reported problem was duplicated. Upon the evaluation, 4 receivers were giving very erratic spo2 and respiration waveforms. Tested with a +3khz and -3khz shift on channel e002. The org was sent in with an old version ad receivers. All 8 receivers with the current version ag were replaced to resolve the noisy signal and intermittent waveforms. All steps in the maintenance check sheet per service manual were completed. The device has been repaired and returned to the customer. 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-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
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 Key5682243
MDR Text Key46220351
Report Number8030229-2016-00222
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 05/26/2016,04/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2016
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 Manufacturer05/10/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/26/2016
Distributor Facility Aware Date04/27/2016
Device Age41 MO
Event Location Hospital
Date Report to Manufacturer05/26/2016
Date Manufacturer Received05/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/27/2012
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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