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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 Failure to Read Input Signal (1581); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 09/12/2016
Event Type  malfunction  
Manufacturer Narrative
The customer reported that there is signal loss on telemetry in one room. Suspect the org has a bad receiver card. 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.
 
Event Description
The customer reported that there is signal loss on telemetry in one room. Suspect the org has a bad receiver card.
 
Manufacturer Narrative
Manufacturer narrative: the customer reported that there is signal loss on telemetry in one room. Suspect the org has a bad receiver card. The device was never sent in for evaluation. Due to the age of this complaint additional information necessary to conduct an investigation is not readily available. Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803. 56 if additional information becomes available. Device not returned.
 
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Brand NameORG-9110A
Type of DeviceMULTIPLE PATIENT RECEIVER
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
attn: shama mooman
tokyo, japan 161-8 560
JA 161-8560
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
1-1 tajino
attn: shama mooman
gunma 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
2687488
MDR Report Key6026949
MDR Text Key57713139
Report Number8030229-2016-00525
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 user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 10/12/2016,09/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2016
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/12/2016
Distributor Facility Aware Date09/12/2016
Event Location Hospital
Date Report to Manufacturer10/12/2016
Date Manufacturer Received10/12/2016
Was Device Evaluated by Manufacturer? No
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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