MAUDE Adverse Event Report: SLEEPSAFE BEDS SLEEPSAFE; SAFETY BED

Model Number SLEEPSAFER

Device Problems Component Missing (2306); Installation-Related Problem (2965)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

Dme technician calls and alleges the user sustained a finger injury.The user caught their finger(s) between the back panel gap.Dme technician advised that the pins that secure panel-to-panel were not installed.Without the dowel pins, the panels can be flexed apart opening a pinch point.The bed was assembled in the home (b)(6) 2017.Technician advised there are no work order notes or other documentation that explain why the pins were not installed.Presumably they were omitted on initial install or possible subsequent move.We are overnighting pins for the technician to install.For preventive action, we will pre-install the pins before we ship.

• Brand Name: SLEEPSAFE
• Type of Device: SAFETY BED
• Manufacturer (Section D): SLEEPSAFE BEDS; 3629 reed creek drive; bassett VA 24055
• Manufacturer (Section G): SAME; same; same VA 24055
• Manufacturer Contact: robert baldacci ; 3629 reed creek drive; bassett, VA 24055 ; 8668522337
• MDR Report Key: 8232172
• MDR Text Key: 132565608
• Report Number: 3008061384-2018-00001
• Device Sequence Number: 1
• Product Code: FNJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: SLEEPSAFER
• Device Catalogue Number: SR-MP-MG-T
• Device Lot Number: 26068
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention