MAUDE Adverse Event Report: POSEY PRODUCTS LLC SELF-REALEASING ROLL BELT; RESTRAINT, PROTECTIVE

Model Number 1135QR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 07/23/2017

Event Type  Death  

Manufacturer Narrative

It was reported that the patient was found deceased while in use with the self-releasing roll belt, but there was no allegation that the device malfunction or functioned in some way to potentially harm the patient.Additionally, there is no evidence to suggest use error or abnormal use may have contributed to the incident.The self-releasing roll belt is indicated for use with patients needing a reminder to call for assistance before exiting a bed who are able to follow instructions, and/or for patients needing a positioning device for added safety while in bed.This product is designed to be self-releasing, and the instructions for use caution that if the patient is not able to easily self-release, the device is considered a restraint and must be prescribed by a physician.The instructions for use were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The application instructions caution the user to check the device for damage and that hook and loop adheres securely.In addition, the ifu has numerous warnings to reduce the risk of serious injury or death.These warnings include always using hospital bed safety workgroup (hbsw) compliant side rails in the up position and to fill all gaps to reduce the risk of entrapment, and using side rail covers and gap protectors to help prevent the patient's body from going under, around, through or between the side rails.Caregivers are warned that there is a risk of chest compression or suffocation if the patient's body weight is suspended off the mattress.Patients should be monitored per facility policy to ensure that the patient cannot slide down or fall off the mattress and become suspended or entrapped.Use of the device should be stopped at once if the patient is at risk to slide forward or down in the device.Before leaving the patient unattended, caregivers are instructed to explain the use of the device to the patient and ensure that the patient understands how to self-release in case of emergency.Based on the information currently available, there is no indication that the device contributed to the event.(b)(4).Pending device return.

Event Description

On sunday (b)(6) 2017 at 8:40 a.M., a nursing home resident that had a restraint prescribed by his treating doctor was found dead.The doctor on call did not sign the death certificate.An autopsy has been carried out and a police investigation is underway to establish the exact circumstances of the death.

• Brand Name: SELF-REALEASING ROLL BELT
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck road; arcadia CA 91006
• Manufacturer Contact: william hincy ; posey products llc; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 6842093
• MDR Text Key: 84748342
• Report Number: 2020362-2017-00066
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nursing Assistant
• Device Model Number: 1135QR
• Device Catalogue Number: 1135QR
• Date Manufacturer Received: 08/17/2017
• 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
• Patient Outcome(s): Death