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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); Communication or Transmission Problem (2896); Incomplete or Inadequate Connection (4037)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2021
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer reported that the multiple patient receiver (org) is having a significant amount of signal loss with their remote telemetry.One patient had a very long pause alarming for asystole and then lost signal, once signal was regained, the patient was back in sinus rhythm.Another patient had a signal loss for about 20 minutes.The biomedical engineer reboot teles and swapped batteries but the unit usually resolves issue on it's own.No patient injury 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.Manufacturer references file (b)(4).
 
Event Description
The biomedical engineer reported that the multiple patient receiver (org) is having a significant amount of signal loss with their remote telemetry.One patient had a very long pause alarming for asystole and then lost signal, once signal was regained, the patient was back in sinus rhythm.Another patient had a signal loss for about 20 minutes.The biomedical engineer reboot teles and swapped batteries but the unit usually resolves issue on it's own.No patient injury reported.
 
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Brand Name
ORG-9110A
Type of Device
MULTIPLE PATIENT RECEIVER
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia
attn: shama mooman
shinjuku-ku, tokyo 161-8 560
JA  161-8560
MDR Report Key11829519
MDR Text Key268118460
Report Number2080783-2021-00286
Device Sequence Number1
Product Code DRG
UDI-Device Identifier04931921103906
UDI-Public04931921103906
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 05/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/14/2021
Distributor Facility Aware Date04/19/2021
Event Location Hospital
Date Report to Manufacturer05/14/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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