MAUDE Adverse Event Report: J. T. POSEY CO. POSEY SITTER ELIT

Model Number 8345

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported the alarm is not functioning properly.Customer has limited info.Customer could not provide the date of event.No pt incident or injury was reported.

Manufacturer Narrative

Evaluation of the alarm found there is a note on the unit stating "keep beeping".The note on the unit is not confirmed, the unit does not sound continuously when in use with the pull magnet.The pre-recorded voice message does not play - only a clicking sound is heard when weight is removed from the sensor or when the pull magnet is removed when is due to a defective voice chip.The tone plays properly.No physical damage observed to the unit.(b)(4).

• Brand Name: POSEY SITTER ELIT
• 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 ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4180377
• MDR Text Key: 16992937
• Report Number: 2020362-2014-00333
• Device Sequence Number: 1
• Product Code: KMI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8345
• Device Catalogue Number: 8345
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/25/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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
• Treatment: MAGNET: 8345M