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

Model Number 1231

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

Patient Problem Death (1802)

Event Date 04/18/2018

Event Type  Death  

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 similar complaints found one other event where a patient was prescribed a roll belt and passed away.No details on what the cause of death was or if the patient was using the device before or at the time of death.Product was not returned for that complaint, so analysis of the unit was not possible.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use (ifu) were reviewed and determined to provide adequate instructions and warnings for safe and effective use of the device.The ifu states "before use, check device for damage.Discard if you have any questions about patient safety.Monitor per facility policy to ensure that the patient cannot slide down, or fall off the mattress and become suspended or entrapped" therefore, no corrective ore preventive actions are necessary.All complaint 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 a patient passed away while possibly wearing the posey belt.No further information was provided at the time of call.Additional information provided by customer on (b)(6) 2018 confirmed product was put into use at the time of death.Customer stated patient was found on her knees next to the hospital bed.Patient was unresponsive when she was found.Cpr was initiated but patient could not be revived.The product has since been disposed of and will not be returning to the manufacturer.

• Brand Name: ROLL BELT
• Type of Device: RESTRAINT, PROTECTIVE
• 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: 7523127
• MDR Text Key: 108600198
• Report Number: 2020362-2018-00039
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963414
• 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: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 1231
• Device Catalogue Number: 1231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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