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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; BED, AC-POWERED ADJUSTABLE HOSPITAL
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; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/13/2017
Event Type  malfunction  
Event Description
While the baby was in the bed, an error stating "bed failed" occurred unprompted.Bed had been functioning normally up until this time.
 
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Type of Device
BED, AC-POWERED ADJUSTABLE HOSPITAL
MDR Report Key7054139
MDR Text Key92881985
Report Number7054139
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 10/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/05/2017
Event Location Hospital
Date Report to Manufacturer10/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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