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

Model Number 33060510

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Crushing Injury (1797); Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

Customer reported that nurse sustained left fourth finger injuries which required in-office medical intervention.Injuries were a result of the finger resting between the side rail assembly and the bed frame while the side rail was being lowered.An evaluation of the device found the bed to be in good working condition with no malfunction found.

Event Description

Customer reported that during training session with device, nurse injured her finger while lowering the side rail when her finger was resting between the side rail and the bed frame.

• Brand Name: BEHAVIORAL HEALTH BED
• 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.); 206 jefferson st.; ellis KS 67637
• Manufacturer Contact: nicholas rose ; 500 commerce pkwy; hays, KS 67601 ; 8168415391
• MDR Report Key: 7016309
• MDR Text Key: 91752635
• Report Number: 1931307-2017-00021
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 33060510
• Device Lot Number: 234529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention