MAUDE Adverse Event Report: J. T. POSEY CO. POSEY CHAIR BELT SENSOR

Model Number 8360

Device Problem False Alarm (1013)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Customer reported when the sensor belt is securely closed, the alarm continues to sound.Customer did not provide a dat when issue was discovered.No patient incident or injury was reported.

Manufacturer Narrative

Results: evaluation of the returned sensor did not confirm continuous sound.The sensor belt was tested with a known working alarm and the alarm does not sound when the male buckle of the sensor belt is detached.Further investigation revealed that the wire inside the sensor belt has been bent and broken.(b)(4).

• Brand Name: POSEY CHAIR BELT SENSOR
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): DONGGUAN POSEY MEDICAL DEVICE CO., LTD.; fumin road, tangli village; fenggang town; donguan/guangdong ; CH
• Manufacturer Contact: roxana koussa ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4174173
• MDR Text Key: 21172837
• Report Number: 2020362-2014-00260
• 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: Unknown
• Type of Report: Initial
• Report Date: 07/17/2014

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: 8360
• Device Catalogue Number: 8360
• Device Lot Number: 3200D10
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/14/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/17/2014
• Initial Date FDA Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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: SITTER ELITE: PART #8345, LOT UNK