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

Model Number 8374

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported the sensor port is damaged, which was found during set up.Customer could not provide the date when found.No pt incident or injury was reported.

Manufacturer Narrative

Evaluation of the alarm did not confirm the reported issue; there is no damage to the sensor receptacle which is working properly.However, when the nurse call cable is plugged into the nurse call receptacle and the nurse call cable is moved, the nurse call red led light toggles on and off.The unit passed all other functional tests.There are scuff marks on the battery door.The alarm has been in service for two years.(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 ; 5635 peck rd.; arcadia, CA 91006 ; 6264433443
• MDR Report Key: 4099194
• MDR Text Key: 4697188
• Report Number: 2020362-2014-00285
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• 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: 08/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2014
• 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
• Treatment: DISPOSABLE SENSOR PAD MODEL: 8283, LOT # UNK