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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC GYRUS, PK-SP GENERATOR
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GYRUS ACMI, INC GYRUS, PK-SP GENERATOR Back to Search Results
Model Number 744000
Device Problems Output below Specifications (3004); Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device was received and evaluated.Evaluation determined that the device exhibited error code 200 ref (b)(4) due to a faulty id board.The output was observed to be low due to faulty psu board.The identified parts were replaced and device was repaired.Once completed, the device was tested and passed all required testing and specifications.Based on evaluation findings the reported failure was found to be due to a faulty id board and psu board attributed to electronic component failure and once replaced, the device was tested with no issues observed.
 
Event Description
It was reported that during an asset return inspection the device exhibited error code 200 ref (b)(4) due to a faulty id board.There was no patient involvement on this report.No user injury reported.
 
Manufacturer Narrative
A dhr review is unable to be performed as this unit has been to service before.Review of the service history record shows that the unit was repaired accordingly.Olympus will continue to monitor complaints for this device.
 
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Brand Name
GYRUS, PK-SP GENERATOR
Type of Device
GYRUS, PK-SP GENERATOR
Manufacturer (Section D)
GYRUS ACMI, INC
136 turnpike road
southborough MA 01772
MDR Report Key10864744
MDR Text Key223769117
Report Number3003790304-2020-00131
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
PMA/PMN Number
K031085
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number744000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2020
Was the Report Sent to FDA? No
Date Manufacturer Received11/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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