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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9100A MULTIPLE PATIENT RECEIVER

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NIHON KOHDEN CORPORATION ORG-9100A MULTIPLE PATIENT RECEIVER Back to Search Results
Model Number ORG-9100A
Device Problems Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2021
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer (bme) reported that the multiple patient receiver (org) is showing communication loss for monitored device(s) for about 2-10 seconds at a time. No patient(s) were harmed. Attempt # 1: on 08/05/2021 emailed the customer via (b)(6) for patient information: no reply was received. Attempt # 2: on 08/18/2021 emailed the customer via (b)(6) for patient information: no reply was received. Attempt # 3: on 08/20/2021 emailed the customer via (b)(6) for patient information: reply was received and no patient demographics were provided. Additional device information: concomitant medical device: the following device(s) were in use in conjunction with the org: central nurse's station: model #: pu-681ra; serial #: (b)(4); device manufacturer data: 09/10/2018' unique identifier (udi) #: (b)(4). Transmitter: model #: zm-920pa; serial #: ni; device manufacturer data: ni; unique identifier (udi) #:(b)(4).
 
Event Description
The biomedical engineer (bme) reported that the multiple patient receiver (org) is showing communication loss for monitored device(s) for about 2-10 seconds at a time. No patient(s) were harmed.
 
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Brand NameORG-9100A
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 Key12368692
MDR Text Key268286082
Report Number2080783-2021-01666
Device Sequence Number1
Product Code DRG
UDI-Device Identifier04931921103883
UDI-Public04931921103883
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 08/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORG-9100A
Device Catalogue NumberORG-9100A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/25/2021
Distributor Facility Aware Date07/29/2021
Device Age3 MO
Event Location Hospital
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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