Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: J. T. POSEY CO. POSEY BED; OYS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

J. T. POSEY CO. POSEY BED; OYS Back to Search Results
Model Number 8060
Device Problems Break (1069); Cut In Material (2454)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Customer reported cuts on the canopy located on both the left and right side panels.Customer also reported a damaged pull tab but did not confirm location.Customer did not provide a date when issue was discovered.No patient incident or injury was reported.
 
Manufacturer Narrative
Results: evaluation of the returned canopy found a slider body open on the patient access of panel side b and a missing slider body on the patient access of panel side a.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
POSEY BED
Type of Device
OYS
Manufacturer (Section D)
J. T. POSEY CO.
arcadia CA
Manufacturer (Section G)
J. T. POSEY CO.
5635 peck rd.
arcadia CA 91006
Manufacturer Contact
roxana koussa
5635 peck rd.
arcadia, CA 91006
6264433143
MDR Report Key3697263
MDR Text Key4248650
Report Number2020362-2013-00528
Device Sequence Number1
Product Code OYS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113355
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 11/13/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8060
Device Catalogue Number8060
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/22/2013
Is the Reporter a Health Professional? No
Date Manufacturer Received12/06/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-