MAUDE Adverse Event Report: J. T. POSEY CO. KEEPSAFE DELUXE

Model Number 8374

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer reported that the connection for the sensor on the alarm is working occasionally.The customer did not know when discovered or the date when found.No pt incident or injury was reported.

Manufacturer Narrative

Evaluation codes : results - evaluation of the returned product confirmed the reported issue; unit sounds on and off when the sensor cable is wiggled.Unit passe all other functional testing.All pins inside the sensor receptacle are bent down.(b)(4).

• Brand Name: KEEPSAFE DELUXE
• 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, admin ; 5635 peck rd.; arcadia, CA 91006 ; 0626443314
• MDR Report Key: 3952959
• MDR Text Key: 21875498
• Report Number: 2020362-2014-00193
• 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: 04/22/2014

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: 8374
• Device Catalogue Number: 8374
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/09/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/22/2014
• Initial Date FDA Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• 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