MAUDE Adverse Event Report: J. T. POSEY CO. FLOOR SENSOR

Model Number 8250S

Device Problem False Alarm (1013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported the floor sensor was in use with the alarm, the sensor only sent signals to the alarm if the pt stepped on certain areas of the mat.Customer did not provide the date when the issue was discovered.The issue was found while in use with a pt but no pt injury was reported.

Manufacturer Narrative

Results: evaluation of the returned sensor confirmed the reported issue.When pressure was applied to the floor sensor, the sensor sent signals to trigger the alarm to sound only on certain spots.The sensor has creases/folds where the majority of the dead spots were found.(b)(4).

• Brand Name: FLOOR SENSOR
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): POSEY, S. DE R.L. DE C.V.; ave ferrocarril no 16901 bodega 64; colonia rio tijuana, 3ra etapa tijuana 2266 4; MX 22664
• Manufacturer Contact: roxana koussa ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4450140
• MDR Text Key: 5393077
• Report Number: 2020362-2015-00015
• 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: Distributor
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8250S
• Device Catalogue Number: 8250S
• Device Lot Number: 4289T078
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/31/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: KEEPSAFE FALL ALARM (PART #8350), LOT UNK