• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9110A MULTIPLE PATIENT RECEIVER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NIHON KOHDEN CORPORATION ORG-9110A MULTIPLE PATIENT RECEIVER Back to Search Results
Model Number ORG-9101A
Device Problems False Alarm (1013); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/21/2016
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the org malfunctioned. The org is giving random duplicate channel alarms on tele 64. No external sources were found to cause this alarm. They are random in occurrence and once cleared with the alarm silence, may not happen again for 10-20 minutes. Currently waiting for the customer to return their device for evaluation. 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 malfunctioned. The org is giving random duplicate channel alarms on tele 64. No external sources were found to cause this alarm. They are random in occurrence and once cleared with the alarm silence, may not happen again for 10-20 minutes.
 
Manufacturer Narrative
The customer reported that the org malfunctioned. The org is giving random duplicate channel alarms on tele 64. No external sources were found to cause this alarm. They are random in occurrence and once cleared with the alarm silence, may not happen again for 10-20 minutes. The unit was cleaned and evaluated. The reported problem of duplicated channel on tele 64 ch-374 was not duplicated, however the evaluation found excessive noise on spo2 waveforms. All malfunctioning parts have been replaced. The unit was tested per the operator's/service manual and the results were recorded on the maintenance check sheet. The unit completed 120 hours of extended testing and operates to manufacturer's specifications. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5892651
MDR Text Key52618881
Report Number8030229-2016-00415
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 08/20/2016,07/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORG-9101A
Device Catalogue NumberORG-9110A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/20/2016
Distributor Facility Aware Date07/21/2016
Device Age53 MO
Event Location Hospital
Date Report to Manufacturer08/20/2016
Date Manufacturer Received08/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/27/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-