MAUDE Adverse Event Report: J. T. POSEY COMPANY SITTER ELITE

Model Number 8345

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Customer reported when the nurse call cable is inserted into the nurse call outlet, it does not send a signal to the nurse call station.Customer reported it was found during set up but could not provide a date when discovered.No patient incident or injury was reported.

Manufacturer Narrative

Results: evaluation of the returned alarm confirmed the reported issue; red led light at the nurse call test fixture does not turn on when the nurse call feature is tested; however, when the nurse cable is wiggled, the red led light turns on and off.Voice only and mute tests cannot be taken due to the unit does not go into voice only and mute modes.Unit passed all other functions.There is a rattling sound from inside the alarm unit and the nurse call receptacle is damaged, but it still secures the nurse call cable.Note: the instructions for use has a statement: the posey sitter elite is an electronic device.It may fail to work if subjected to severe shock, such as being dropped, or immersed in liquid.To reduct the risk of serious injury or death, test the alarm and sensor for proper operation prior to putting in service with a patient, and each time before leaving the patient unattended.If the alarm and/or sensor do not function properly, remove the alarm and sensor from service and replace them with a properly functioning alarm and/or sensor.Do not use the alarm, sensor or magnet if it does not activate each time weight is removed from the sensor, the chair belt sensor is unfastened, or magnet is removed from face plate.

• Brand Name: SITTER ELITE
• Manufacturer (Section D): J. T. POSEY COMPANY; arcadia CA
• Manufacturer (Section G): J. T. POSEY COMPANY; 5635 peck road; arcadia CA 91006
• Manufacturer Contact: pam wampler, prod surv admin ; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3868509
• MDR Text Key: 17296674
• Report Number: 2020362-2014-00181
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8345
• Device Catalogue Number: 8345
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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: NURSE CALL CABLE: PN 8282