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 COMPANY SITTER SELECT
  • 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 COMPANY SITTER SELECT Back to Search Results
Model Number 8361
Device Problem Defective Alarm (1014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
The customer reported that when the alarm is sounding and the hold button is pushed, the alarm continues to sound.The customer did not know when this was discovered or the date when the issue was found.No patient incident or injury was reported.
 
Manufacturer Narrative
Results: evaluation of returned alarm confirmed the reported issue.However, when the nurse call function was tested, the led light does not come on at the nurse call test fixture as it should.No physical damages found to the alarm unit.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SITTER SELECT
Manufacturer (Section D)
J. T. POSEY COMPANY
arcadia CA
Manufacturer (Section G)
J. T. POSEY COMPANY
5635 peck rd.
arcadia CA 91006
Manufacturer Contact
pam wampler
5635 peck rd.
arcadia, CA 91006
6264433143
MDR Report Key3856462
MDR Text Key4660979
Report Number2020362-2014-00155
Device Sequence Number1
Product Code KMI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/12/2014
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 Number8361
Device Catalogue Number8361
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/20/2014
Initial Date FDA Received04/18/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
LOT # UNK; 30-DAY OVER MATTRESS BED SENSOR: MODEL: 8283,
-
-