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

Model Number 8374

Device Problem Defective Alarm (1014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported the alarm does sound; however, the voice recording does not.Batteries have been replaced with a new supply and no visible damage reported.Customer could not provide the date when discovered.No pt incident or injury reported.

Manufacturer Narrative

Eval of the returned product confirmed the reported issue is confirmed.Factory message does not play and a clicking noise sounds in its place.Tone plays when it should.Unit passes all other functional tests.No physical damage observed.(b)(4).

• Brand Name: POSEY 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 ; 6264433143
• MDR Report Key: 3847720
• MDR Text Key: 4407622
• Report Number: 2020362-2014-00077
• 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: 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: 8374
• Device Catalogue Number: 8374
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/28/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2014
• Initial Date FDA Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• 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: OVER-THE-MATTRESS SENSOR PAD: MODEL 8307, LOT #UNK