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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 Device Damaged Prior to Use (2284)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Customer reported the zipper is broken on the ride side panel.The issue was discovered during set up, but the date of the event is unknown.No patient incident of injury was reported.
 
Manufacturer Narrative
Evaluation codes: results - evaluation of the returned product confirmed the reported issue and revealed that the patient access window side left has one zipper tooth element missing.Additionally, the upper zipper slider is stuck.No other damages were observed.(b)(4).
 
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Brand Name
POSEY BED
Manufacturer (Section D)
J. T. POSEY CO.
arcadia CA
Manufacturer (Section G)
PSOEY, 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 rd.
arcadia, CA 91006
6264433413
MDR Report Key3998304
MDR Text Key15328338
Report Number2020362-2014-00234
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 06/09/2014
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 Manufacturer06/06/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/09/2014
Initial Date FDA Received06/30/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2013
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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