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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 Problem Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2019
Event Type  malfunction  
Manufacturer Narrative
The customer reported that their central nurse's station (cns) is showing communication loss for a single multiple patient receiver (org). Nk ts logged into the system and found that this org does not show in the org settings or the cns host table. No patient harm or injury was reported. The customer will be sending the failed unit in for a repair and further 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. Additional device information: the following devices were used in conjunction with the org, but did not experience failure: cns - model: pu-621ra: s/n: (b)(4). Approximate age of the device: 54 months. Device manufacturer date: 05/29/2019 unique identifier (udi) #: (b)(4). Attempts to obtain the following information were made, but not provided: variety of transmitters - model #: ni, s/n #: ni. Approximate age of the device: ni. No serial number was provided, so the age of the device is unknown. Device manufacturer date: ni, unique identifier (udi) #: ni.
 
Event Description
The customer reported that their central nurse's station (cns) is showing communication loss for a single multiple patient receiver (org).
 
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Brand NameORG-9100A
Type of DeviceMULTIPLE PATIENT RECEIVER
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
attn: shama mooman
tokyo, 161-8 560
JA 161-8560
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
1-1 tajino
attn: shama mooman
tomioka city, 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
MDR Report Key9441074
MDR Text Key200824577
Report Number8030229-2019-00712
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 health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/18/2020
Distributor Facility Aware Date02/13/2020
Device Age56 MO
Event Location Hospital
Date Report to Manufacturer02/18/2020
Date Manufacturer Received02/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/12/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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