MAUDE Adverse Event Report: J. T. POSEY CO. EXIT ALARM, SMALL 36" X 24

Model Number 8250S

Device Problems No Audible Alarm (1019); Failure to Sense (1559)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Date 06/04/2014

Event Type  malfunction  

Event Description

Customer reported when the patient stepped on the floor sensor mat, the alarm did not sound.The patient fell but was not injured.The customer tested the sensor mat with the alarm units with the same results.The customer also checked the alarm with several other sensor pads and the alarm functions correctly.

Manufacturer Narrative

Lot number from distributor was reported as (b)(4).This could not be confirmed on the actual product returned due to labeling with lot identifier is missing and the product was not returned in the original packaging.Results (other) - the exit alarm was tested with a known working alarm unit and the alarm does not sound when weight is applied to the exit alarm mat.The exit alarm mat was received in a non-posey box.The serial/lot number on the exit alarm mat is missing.There are creases on the exit alarm mat, likely from the unit being folded.(b)(4).

• Brand Name: EXIT ALARM, SMALL 36" X 24
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): J. T. POSEY CO.; de r.l. de c.v. ave. ferrocarril no. 16901; bodega tijuana CP 2 2664; MX CP 22664
• Manufacturer Contact: pam wampler, administrator ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3979477
• MDR Text Key: 4754991
• Report Number: 2020362-2014-00240
• Device Sequence Number: 1
• Product Code: KMI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2014
• 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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/02/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1