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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); Intermittent Communication Failure (4038)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/15/2021
Event Type  malfunction  
Event Description
The biomedical engineer (bme) reported that the multiple patient receiver (org's) keep losing connectivity and shows communication loss with connected device(s). No patient harm was reported. Nihon kohden's technician advised the bme to work with their it department due to having nihon kohden's equipment running off of their facilities network which means the switches being used for the org's are serviced by the facilities it department.
 
Manufacturer Narrative
The biomedical engineer (bme) reported that the multiple patient receiver (org's) keep losing connectivity and shows communication loss with connected device(s). No patient harm was reported. Nihon kohden's technician advised the bme to work with their it department due to having nihon kohden's equipment running off of their facilities network which means the switches being used for the org's are serviced by the facilities it department. 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.
 
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Brand NameORG-9110A
Type of DeviceMULTIPLE 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 Key12456879
MDR Text Key283501100
Report Number8030229-2021-01645
Device Sequence Number1
Product Code DRG
UDI-Device Identifier04931921103906
UDI-Public04931921103906
Combination Product (y/n)N
PMA/PMN Number
K071058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial
Report Date 09/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2021
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/10/2021 Patient Sequence Number: 1
Treatment
MULTIPLE PATIENT RECEIVER'S ORG'S; MULTIPLE TELEMETER(S)
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