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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 Problems Break (1069); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/24/2014
Event Type  malfunction  
Event Description
Customer reported the zipper located at the right side panel is broken, damage to the teeth.Customer also states: zipper pulled apart.This was discovered during set up and no pt incident or injury was reported.
 
Manufacturer Narrative
Results: eval of the returned product confirmed the reported issue: the right side pt access window zipper slider body is open.Right iv zipper, both right and left leg covers zippers are stuck.(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.
ferocarril no. 16901
bodega tijuana C.P. 226
MX   C.P. 2266
Manufacturer Contact
pam wampler, admin
5635 peck rd.
arcadia, CA 91006
6264433143
MDR Report Key3847764
MDR Text Key20788937
Report Number2020362-2014-00092
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 Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2014
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 Manufacturer03/06/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received03/11/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2009
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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