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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: J. T. POSEY CO. SITTER II
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J. T. POSEY CO. SITTER II Back to Search Results
Model Number 8281
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Customer reported that they are unable to adjust the volume on the alarm.Customer did not provide a date when the issue was discovered.No pt incident or injury was reported.
 
Manufacturer Narrative
Results: eval of the returned product did not confirm the reported issue; alarm volumes can be adjusted.However, the low battery light did not come on when tested.When the alarm volume is set at the highest level, the display will dim as the tone sounds and when the factor voice message or custom recorded voice message plays.(b)(4).
 
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Brand Name
SITTER II
Manufacturer (Section D)
J. T. POSEY CO.
arcadia CA
Manufacturer (Section G)
J. T. POSEY CO.
5635 peck rd.
arcadia CA 91006
Manufacturer Contact
pam wampler, admin
5635 peck rd.
arcadia, CA 91006
6264433143
MDR Report Key3770334
MDR Text Key4436546
Report Number2020362-2014-00047
Device Sequence Number1
Product Code KMI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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 01/13/2014
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 Number8281
Device Catalogue Number8281
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/22/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/27/2014
Initial Date FDA Received02/18/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2002
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
OVER-THE-MATTRESS SENSOR PAD, MODEL: 8307,; LOT # UNK
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