MAUDE Adverse Event Report: J. T. POSEY COMPANY OVER MATTRESS SENSOR PAD

Model Number 8307

Device Problem False Alarm (1013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported the alarm sounds intermittently while in use with the sensor.Customer tested the alarm with a known working sensor and the alarm is functioning properly.Discovered during use with a patient however, customer could not provide the date when found.No patient incident or injury reported.

Manufacturer Narrative

Product has been requested to be returned but has not been returned.No lot number of the product provided.This report is made solely based on the customer's claim.(b)(4).

• Brand Name: OVER MATTRESS SENSOR PAD
• Manufacturer (Section D): J. T. POSEY COMPANY; arcadia CA
• Manufacturer (Section G): J. T. POSEY MEDICAL DEVICE CO. LTD; fumin road, tangli village, fenggang town; dongguan; guangdon ; CH
• Manufacturer Contact: pam wampler, product surveill ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3868575
• MDR Text Key: 4455048
• Report Number: 2020362-2014-00167
• Device Sequence Number: 1
• Product Code: KMI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2014

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: 8307
• Device Catalogue Number: 8307
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: KEEPSAFE DELUXE: MODEL 8374, SN UNK