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

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).

• 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 Key: 3937428
• MDR Text Key: 16089536
• Report Number: 2020362-2014-00223
• Device Sequence Number: 1
• Product Code: KMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Number: 8283
• Device Catalogue Number: 8283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2014
• Initial Date FDA Received: 06/23/2014
• 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 Number: 1
• Treatment: POSEY SITTER ELITE MODEL: 8345 SN UNK