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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CENTRAL MONITORING SYSTEM CENTRAL MONITORING STATION

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NIHON KOHDEN CORPORATION CENTRAL MONITORING SYSTEM CENTRAL MONITORING STATION Back to Search Results
Model Number EDNS-9001
Device Problems Loss of Power (1475); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/26/2016
Event Type  malfunction  
Manufacturer Narrative
The customer states that the prefense monitor will only come on for a short duration, then powers off. The biomedical engineer verified that a different monitor works (another bme has a spare monitor on the system and they are monitoring patients). The customer was transferred to customer service for the pricing of a new monitor. 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 states that the prefense monitor will only come on for a short duration, then powers off.
 
Manufacturer Narrative
The customer states that the prefense monitor will only come on for a short duration, then powers off. The biomedical engineer verified that a different monitor works (another bme has a spare monitor on the system and they are monitoring patients). The customer was transferred to customer service for the pricing of a new monitor. The device was never sent in for evaluation as the customer was looking into getting a new monitor. 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.
 
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Brand NameCENTRAL MONITORING SYSTEM
Type of DeviceCENTRAL MONITORING STATION
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
attn: shama mooman
tokyo, japan CA 161-8 560
JA 161-8560
Manufacturer (Section G)
NKUS LAB
5 jenner, suite 180
attn: shama mooman
gunma CA
JA
Manufacturer Contact
shama mooman
safety mgmt dept, quality mgm
seibu bldg 2, 4th floor 1-11-2
kusunokidai tokorozawa, saitama, CA 359-8-580
JA   359-8580
9492687708
MDR Report Key5462342
MDR Text Key39424004
Report Number2032233-2016-00079
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102106
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 01/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEDNS-9001
Device Catalogue NumberEDNS-9001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/29/2011
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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