MAUDE Adverse Event Report: RAYES, INC. (D/B/A SUNFLOWER MEDICAL L.L.C.) MIGHTY REST; AC-POWERED ADJUSTABLE HOSPITAL BED

Model Number CB86

Device Problem Installation-Related Problem (2965)

Patient Problem Laceration(s) (1946)

Event Date 01/28/2016

Event Type  Injury  

Manufacturer Narrative

Customer did not allege that the device itself malfunctioned, but that during the installation of the trapeze it was mishandled and struck the patient.A review of training records for employees involved in installation of trapeze confirmed that appropriate training was completed.Device not returned to manufacturer.

Event Description

During installation of trapeze onto bed, overhead bar was dropped on patient's head.Patient sustained a three inch laceration which required visit to emergency department.

• Brand Name: MIGHTY REST
• Type of Device: AC-POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): RAYES, INC. (D/B/A SUNFLOWER MEDICAL L.L.C.); 206 jefferson st.; ellis KS 67637
• Manufacturer (Section G): RAYES, INC. (D/B/A SUNFLOWER MEDICAL L.L.C.); 500 commerce plwy; hays KS 67601
• Manufacturer Contact: nicholas rose ; 206 jefferson st; ellis, KS 67637 ; 8168415391
• MDR Report Key: 6568102
• MDR Text Key: 75209260
• Report Number: 1931307-2017-00016
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: E167020
• 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: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: CB86
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2016
• 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): Hospitalization