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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: J. T. POSEY CO. SINGLE PATIENT USE OVER-MATTRESS SENSOR PAD

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J. T. POSEY CO. SINGLE PATIENT USE OVER-MATTRESS SENSOR PAD Back to Search Results
Model Number 8283
Device Problems Device Alarm System (1012); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)
Patient Problem Fall (1848)
Event Type  Other  
Event Description
The customer stated the patient was found on the floor and the alarm was not sounding due to a nurse call light controller was lying on the sensor.The facility had the sensor on a low-air mattresses or overlays.A foam pad on top of the mattress may diffuse patient weight and prevent sensor from activating".Customer claims the alarm itself is working properly and has since discarded the sensor pad.Customer did not provide the date the event occurred.No injury to the patient was reported.
 
Manufacturer Narrative
Customer has discarded the sensor and did not provide a lot number of the sensor.Customer admitted to using the sensor on a low-air mattress which goes against the instructions for use warning.The customer has been made aware if they are to use a low-air mattress to use the magnet clip mode and not the sensor for monitoring the patient.The alarm in use is working as it should.This is being reported as a conservative measure and is based solely on the customers claim.Manufacturer references file # (b)(4).
 
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Brand Name
SINGLE PATIENT USE OVER-MATTRESS SENSOR PAD
Manufacturer (Section D)
J. T. POSEY CO.
arcadia CA
Manufacturer Contact
pam wampler, admin
5635 peck rd.
arcadia, CA 91006
6264433143
MDR Report Key3937428
MDR Text Key16089536
Report Number2020362-2014-00223
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 User Facility,Company Representative
Reporter Occupation Unknown
Type of Report Initial
Report Date 05/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number8283
Device Catalogue Number8283
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/19/2014
Initial Date FDA Received06/23/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
POSEY SITTER ELITE MODEL: 8345 SN UNK
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