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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. IMAGE MANAGEMENT HUB

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OLYMPUS MEDICAL SYSTEMS CORP. IMAGE MANAGEMENT HUB Back to Search Results
Model Number IMH-20
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/30/2019
Event Type  malfunction  
Manufacturer Narrative
The subject imh-20 was returned to olympus medical systems corp.(omsc) for evaluation.Omsc confirmed the subject device, and the reported event was not reproduced.Omsc checked the log file of the subject device and confirmed the following the records.The operation log after 14:31 on (b)(6) 2019 is not recorded on the subject device.The system shut down at 15:30 on (b)(6) 2019.The subject device restarted at 17:34 on (b)(6) 2019.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Since the event was not reproduced, the exact cause has been unknown; however, the following are supposed to be the cause.A malfunction occurred temporarily on the motherboard or memory of the subject device.The instruction manual of the subject device states the corresponding method in case of an abnormality.There were no further details provided.If significant additional information is received, this report will be supplemented.
 
Event Description
During the unspecified procedure with the imh-20, the drive indicator on the front panel of the subject device was lit orange and the endoscopic images could not recorded on the subject device.The user replaced the subject device to another unspecified system including the unspecified recorder to complete the procedure.After the procedure, the user turned on the subject device, the subject device worked properly.There was no report of the patient injury other than replacing the device.
 
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Brand Name
IMAGE MANAGEMENT HUB
Type of Device
IMAGE MANAGEMENT HUB
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
MDR Report Key9243543
MDR Text Key213501657
Report Number8010047-2019-03726
Device Sequence Number1
Product Code LMB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
CLASS1-EXMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberIMH-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/30/2019
Initial Date FDA Received10/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/18/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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