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
  • 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 Back to Search Results
Model Number 8060
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Customer reported when a pt applied pressure from inside the canopy, it caused the zipper teeth to separate at the bottom left corner of the canopy.Customer could not provide the date of event.No pt incident or injury was reported.
 
Manufacturer Narrative
Results - evaluation of the returned product found a zipper slider body is open on the front side window.Also, the front posey label is torn.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
ferrocarril no 16901
bodege tijuana CP 2 2664
MX   CP 22664
Manufacturer Contact
pam wampler
5635 peck rd.
arcadia, CA 91006
6264433143
MDR Report Key4374462
MDR Text Key5112708
Report Number2020362-2014-00420
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 Unknown
Type of Report Initial
Report Date 09/08/2014
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 Number8060
Device Catalogue Number8060
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/17/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/08/2014
Initial Date FDA Received12/24/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-