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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SCHAERER SCHAERER 7300 CYSTOCOPY BED

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SCHAERER SCHAERER 7300 CYSTOCOPY BED Back to Search Results
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/02/2019
Event Type  malfunction  
Event Description
The bed could not be brought up to height using remote or external buttons.
 
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Brand NameSCHAERER 7300
Type of DeviceCYSTOCOPY BED
Manufacturer (Section D)
SCHAERER
675 wilmer ave
cincinnati OH 45226
MDR Report Key9859825
MDR Text Key184278552
Report Number9859825
Device Sequence Number1
Product Code JEB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/04/2020
Event Location No Information
Date Report to Manufacturer03/20/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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