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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 Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Customer reported a rip at the end of the zipper.Customer also reported damage to the slider and teeth located at the head end of the panel.Customer did not provide the date when issue was found.No pt incident or injury reported.
 
Manufacturer Narrative
Results: eval of the returned bed found the right side pt access window zipper slider body is open and is broken.Panel side head has nylon material is frayed on the leg cover.Panel foot side left leg cover and right leg cover has broken stitches.(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.
ferrocarri 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 Key3847719
MDR Text Key4618305
Report Number2020362-2014-00076
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 01/28/2014
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 Manufacturer02/13/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/14/2014
Initial Date FDA Received03/18/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2009
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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