MAUDE Adverse Event Report: POSEY PRODUCTS LLC LOW PRESSURE SENSOR PAD; MONITOR, BED PATIENT

Model Number 8317

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

Product was discarded and will not be returned.This report is based solely on the information provided by the customer.An investigation of historical complaints found no other documentation that was similar to the issues of this report.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instruction for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.The instructions for use state "always test sensor and alarm system for proper function before leaving patient unattended." therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.(b)(4).Product had been discarded.

Event Description

Customer reported there is an occurrence of pressure ulcers with patients using the low pressure mattress sensor pad.The date the issue was identified was not reported.

• Brand Name: LOW PRESSURE SENSOR PAD
• Type of Device: MONITOR, BED PATIENT
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck rd; arcadia CA 91006
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 7162935
• MDR Text Key: 96330742
• Report Number: 2020362-2017-00085
• 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 faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 8317
• Device Catalogue Number: 8317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other