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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION AG-920RA MULTI-GAS UNIT

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NIHON KOHDEN CORPORATION AG-920RA MULTI-GAS UNIT Back to Search Results
Model Number AG-920RA
Device Problems Failure to Sense (1559); Device Stops Intermittently (1599)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/11/2017
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the multi gas unit was giving only intermittent readings while on a case. This device was sent in once before for the same issue the determination then was "cannot duplicate. " the bme sent the device in for repair. The unit was cleaned and evaluated and the reported problem was not duplicated, however the device would intermittently not zero cal and some readings were off. All malfunctioning parts were replaced. The unit was tested per operator's/service manual. The unit completed 24 hours of extended testing and operates to manufacturer's specifications. Nihon kohden continues to investigate the reported event. Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available.
 
Event Description
The customer reported that the multi gas unit was giving only intermittent readings while on a case.
 
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Brand NameAG-920RA
Type of DeviceMULTI-GAS UNIT
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
tomioka city, 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 Key6556075
MDR Text Key74792326
Report Number8030229-2017-00133
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 05/09/2017,04/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAG-920RA
Device Catalogue NumberAG-920RA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/09/2017
Distributor Facility Aware Date04/11/2017
Device Age61 MO
Event Location Hospital
Date Report to Manufacturer05/09/2017
Date Manufacturer Received05/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/13/2012
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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