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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 Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/08/2017
Event Type  malfunction  
Manufacturer Narrative
Corrected data : device evaluated by manufacturer. Additional manufacturer narrative: the customer reported that the multi gas unit stopped producing gas readings while in the middle of a case. The readings would come back if the glass was tapped. No patient harm was reported. The customer has sent the unit in for evaluation. The unit was cleaned and evaluated. The reported problem of "gas measurement is dropping off" was duplicated. All malfunctioning parts were replaced. The unit was tested per the operator's/service manual and completed 24 hours of extended testing. The unit operates to manufacturer's specifications and has been sent back to the customer.
 
Manufacturer Narrative
The customer reported that the multi gas unit stopped producing gas readings while in the middle of a case. The readings would come back if the glass was tapped. No patient harm was reported. They sent the device in for repair and it is currently awaiting evaluation. 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 stopped producing gas readings while in the middle of a case. The readings would come back if the glass was tapped.
 
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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, 161-8 560
JA 161-8560
MDR Report Key7162921
MDR Text Key286925431
Report Number8030229-2018-00002
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
PMA/PMN Number
K020046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup,Followup
Report Date 10/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAG-920RA
Device Catalogue NumberAG-920RA
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2017
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/07/2019
Distributor Facility Aware Date10/03/2019
Device Age101 MO
Event Location Hospital
Date Report to Manufacturer10/07/2019
Date Manufacturer Received10/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberNOT APPLICABLE

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