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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 Date 04/22/2014
Event Type  malfunction  
Event Description
Customer reported while a pt was occupying the canopy bed, the pt was able to unzip the side panel, but no fall occurred.No pt serious injury was reported.
 
Manufacturer Narrative
Product was requested to be returned for evaluation and has not been received.Customer did not provide a posey bed serial number.Note: this report is submitted based on the customer reported issue statement.(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 rd.
arcadia, CA 91006
6264433143
MDR Report Key4001322
MDR Text Key4705504
Report Number2020362-2014-00245
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,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 06/19/2014
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/19/2014
Initial Date FDA Received07/21/2014
Was Device Evaluated by Manufacturer? No
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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