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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 Communication or Transmission Problem (2896); Wireless Communication Problem (3283)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/28/2019
Event Type  malfunction  
Manufacturer Narrative
They put a loaner in its place once they realized there was an issue. After checking the warranty status (which was no longer valid), they informed nk they will need to find another option for replacement. 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 biomedical engineer (bme) reported that the org had multiple receiver card failures, which occurred intermittently.
 
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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, 161-8 560
JA 161-8560
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
1-1 tajino
attn: shama mooman
tomioka city, 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 Key8714648
MDR Text Key149502418
Report Number8030229-2019-00231
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 09/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORG-9110A
Device Catalogue NumberORG-9110A
Device Lot NumberNOT APPLICABLE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/26/2019
Distributor Facility Aware Date09/11/2019
Device Age78 MO
Event Location Hospital
Date Report to Manufacturer09/26/2019
Date Manufacturer Received09/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/07/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberNOT APPLICABLE

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