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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: J. T. POSEY CO. POSEY BED; OYS
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J. T. POSEY CO. POSEY BED; OYS Back to Search Results
Model Number 8070
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Results: evaluation of the returned product found on the left side window zipper, one element is missing and on the perimeter guard one element is missing.(b)(4).
 
Event Description
Customer reported zipper damage to the canopy.Customer has limited information and did not provide a date when issue was discovered.No patient incident or injury was reported.
 
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Brand Name
POSEY BED
Type of Device
OYS
Manufacturer (Section D)
J. T. POSEY CO.
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
MX  
Manufacturer Contact
roxana koussa
5635 peck rd.
arcadia, CA 91006
6264433143
MDR Report Key3881055
MDR Text Key15882278
Report Number2020362-2014-00128
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 Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/07/2014
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 Manufacturer03/06/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/07/2014
Initial Date FDA Received04/08/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2011
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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