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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 Signal Artifact/Noise (1036); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2021
Event Type  malfunction  
Manufacturer Narrative
The customer's contractor reported that the multiple patient receiver (org) was having intermittent signal loss and dropouts in a certain area of the hospital.It is happening in rooms 318-321 only and is gradually getting worse.No patient harm reported.Nihon kohden field service technician went to facility and replaced a power supply which resolved the issue.
 
Event Description
The customer's contractor reported that the multiple patient receiver (org) was having intermittent signal loss and dropouts in a certain area of the hospital.It is happening in rooms 318-321 only and is gradually getting worse.No patient harm reported.
 
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Brand Name
ORG-9110A
Type of Device
MULTIPLE PATIENT RECEIVER
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
attn: shama mooman
1-31-4 nishiochia
shinjuku-ku, tokyo 161-8 560
JA  161-8560
MDR Report Key12170935
MDR Text Key280573810
Report Number2080783-2021-00410
Device Sequence Number1
Product Code DRG
UDI-Device Identifier04931921103906
UDI-Public04931921103906
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberORG-9110A
Device Catalogue NumberORG-9110A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/14/2021
Distributor Facility Aware Date06/14/2021
Device Age119 MO
Event Location Hospital
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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