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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: J. T. POSEY CO. POSEY BED
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J. T. POSEY CO. POSEY BED Back to Search Results
Model Number 8070
Device Problem Material Separation (1562)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
Customer reported the zipper, which is used to close the foam padding compartment on the top of the bed is completely missing.Customer reported this was discovered during set up, but did not provide the date when found.No patient incident or injury was reported.
 
Manufacturer Narrative
Results: evaluation of the returned bed shows one zipper element is missing on the left side panel molding zipper.The bed has tears in several areas and the mattress envelope material is delaminated.Management reviews all complaints on a monthly basis and any increase in trends will be handled accordingly.(b)(4).
 
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Brand Name
POSEY BED
Manufacturer (Section D)
J. T. POSEY CO.
arcadia CA
Manufacturer (Section G)
J. T. POSEY CO. DE R.L. DE C.V.
ave. ferrocarril no. 16901
bodega tijuana 2266 4
MX   22664
Manufacturer Contact
pam wampler
5635 peck rd.
arcadia, CA 91006
6264433143
MDR Report Key4019362
MDR Text Key4846637
Report Number2020362-2014-00235
Device Sequence Number1
Product Code OYS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103817
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/18/2014
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 Health Professional
Device Model Number8070
Device Catalogue Number8070
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/18/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/18/2014
Initial Date FDA Received07/08/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2011
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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