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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: J. T. POSEY COMPANY POSEY BED
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J. T. POSEY COMPANY POSEY BED Back to Search Results
Model Number 8070
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Customer reported damage to the slider, teeth, and zipper located on the left side panel.The date of the event is unknown.No patient incident or injury was reported.
 
Manufacturer Narrative
Results: evaluation of returned product confirmed the reported issue.The patient access panel right molding zipper is missing one tooth element.Additionally, the perimeter guard zipper insert pin is missing and the mattress envelope is delaminated.(b)(4).
 
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Brand Name
POSEY BED
Manufacturer (Section D)
J. T. POSEY COMPANY
arcadia CA
Manufacturer (Section G)
POSEY, S. DE R.L. DE C.V.
ave. ferrocarril no. 16901. bodega 64
colonia rio tijuana, 3ra. etapa
tijuana 2266 4
MX   22664
Manufacturer Contact
mary segura
5635 peck road
arcadia, CA 91006
6264433143
MDR Report Key4220354
MDR Text Key5068270
Report Number2020362-2014-00255
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 07/09/2014
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 Manufacturer07/02/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/09/2014
Initial Date FDA Received08/06/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2010
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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