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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SLEEPSAFE BEDS SLEEPSAFE SAFETY BED

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SLEEPSAFE BEDS SLEEPSAFE SAFETY BED Back to Search Results
Model Number SLEEPSAFER
Device Problems Component Missing (2306); Installation-Related Problem (2965)
Patient Problem Injury (2348)
Event Type  Injury  
Event Description
Dme technician calls and alleges the user sustained a finger injury. The user caught their finger(s) between the back panel gap. Dme technician advised that the pins that secure panel-to-panel were not installed. Without the dowel pins, the panels can be flexed apart opening a pinch point. The bed was assembled in the home (b)(6) 2017. Technician advised there are no work order notes or other documentation that explain why the pins were not installed. Presumably they were omitted on initial install or possible subsequent move. We are overnighting pins for the technician to install. For preventive action, we will pre-install the pins before we ship.
 
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Brand NameSLEEPSAFE
Type of DeviceSAFETY BED
Manufacturer (Section D)
SLEEPSAFE BEDS
3629 reed creek drive
bassett VA 24055
Manufacturer (Section G)
SAME
same
same VA 24055
Manufacturer Contact
robert baldacci
3629 reed creek drive
bassett, VA 24055
8668522337
MDR Report Key8232172
MDR Text Key132565608
Report Number3008061384-2018-00001
Device Sequence Number1
Product Code FNJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Remedial Action Repair
Type of Report Initial
Report Date 01/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberSLEEPSAFER
Device Catalogue NumberSR-MP-MG-T
Device Lot Number26068
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/09/2019 Patient Sequence Number: 1
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