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

Model Number 8374

Device Problem False Alarm (1013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer reported that the alarm is still alarming even though the hold/suspend button has been pressed.The alarm was tested with a test strip.The customer did not provide the date of the event.No pt incident or injury was reported.

Manufacturer Narrative

Results - eval of the returned product found the pre-recorded message does not play - only a single click can be heard when weight is removed from the sensor pad, due to a faulty voice chip.The tone can be heard.The alarm does not sound continuously when put in hold/suspend mode.When the unit is powered on with an external power supply to test the low battery function, the unit lost power.When the unit was retested for power using batteries the unit does not power on.The unit has power using the 9v power adapter.This is evidence of a faulty 9v adaptor.The unit has been exposed to moisture and there is battery leakage on the battery contacts.There are scrapes on the green over mold on the alarm case.The mfr date indicates that this unit has been in service for four 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 ; 6264433143
• MDR Report Key: 4148388
• MDR Text Key: 4784432
• Report Number: 2020362-2014-00320
• 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: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• 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: 09/05/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2008
• 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: OVER-THE-MATTRESS SENSOR PAD MODEL #8307 LOT # UNK