MAUDE Adverse Event Report: RAYES INC. (D/B/A SUNFLOWER MEDICAL L.L.C) BARI REHAB PLATFORM 2; AC-POWERED ADJUSTABLE HOSPITAL BED

Model Number BSWRP2

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 08/09/2018

Event Type  Injury  

Manufacturer Narrative

Investigation found device was in good working condition with no malfunction found, and that injury was a result of customer's failure to follow proper instructions/methods for removal of side rail.Customer reported that staff sustained cut to finger which required stitches.

Event Description

Patient reported witnessing a customer staff member attempt to remove a side rail at the foot end of a bari rehab platform 2 bed.Patient noted the staff member did not remove the side rail lock pin before attempting to remove the side rail, causing the staff member to struggle.Staff member did eventually work the rail free, but cut himself in the process on the metal brace that attaches the rail to the bed frame.Cut required stitches.

• Brand Name: BARI REHAB PLATFORM 2
• 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): RAYE'S 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: 7857585
• MDR Text Key: 119641052
• Report Number: 0001931307-2018-00009
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/09/2018

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: No Information
• Device Model Number: BSWRP2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/09/2018
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention