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

Model Number 8281

Device Problems No Audible Alarm (1019); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported the alarm has power, but does not sound when weight is removed from the sensor.Also, the led light does not light up.The date when the issue was discovered is unk.No pt incident or injury reported.

Manufacturer Narrative

Evaluation codes: results: (other) - evaluation of the returned product confirmed the reported issue.The unit powers up, but the alarm does not sound when weight is removed from the sensor pad.The red led low battery indicator works as it should, but , the fail safe does not work.The nurse call light turns off intermittently at the nurse call test fixture when the nurse call test fixture when the nurse call cable is wiggled.

• Brand Name: SITTER II
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): J. T. POSEY CO.; 5635 peck rd.; arcadia CA 91006
• Manufacturer Contact: mary segura ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3932858
• MDR Text Key: 4573681
• Report Number: 2020362-2014-00074
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8281
• Device Catalogue Number: 8281
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/26/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2014
• Initial Date FDA Received: 03/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2008
• 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: BED SENSOR PAD: MODEL 8307, LOT # UNK