MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. ARJOHUNTLEIGH ROTOPRONE

Model Number ROTOPRONE

Device Problems Unintended System Motion (1430); Device Operates Differently Than Expected (2913)

Patient Problem Fall (1848)

Event Date 02/02/2014

Event Type  No Answer Provided  

Event Description

Rotoprone bed was not working properly.As patient was supine, rotation therapy was started.Limits were set at 45 degrees for left and right rotation.Bed rotated patient greater than 60 degrees and patient almost fell out of the bed.Nurses had to hold patient in the bed while the cpr button at the computer site was pushed to bring the patient back down to 0 degrees supine.Also, bed would not allow proper functioning during normal therapy settings.On (b)(6) the representative was called because we had 2 issues with the rotoprone beds at that time.The issues included: receipt of dirty bed from vendor.It was noted that each bed is cleaned and has a thorough quality control inspection prior to the delivery of the bed, and yet a dirty bed was received at our facility and proof that this process did not take place.This process takes approximately 4-8 hours for completion.Upon arrival of the bed the quality control checklist is provided to the hospital and checked as proof of the inspection; issues with head support system- post investigation determined was the result of stripped bolt, rep admitted to instructing rn to tie up the head support in order to make it operational, additionally he stated he would never make that statement again instead he would encourage the rn to manually prone the patient or to move the patient to a standard bed and then manually prone the patient we informed him that our nurses are asked to not modify equipment outside manufacturer guidelines.Rotoprone bed delivered for use on (b)(6) 2014 and taken out of service on (b)(6) 2014, for equipment malfunction over rotation past designated 45 degrees programming.

• Brand Name: ARJOHUNTLEIGH ROTOPRONE
• Type of Device: ARJOHUNTLEIGH ROTOPRONE
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; addison IL 60101
• MDR Report Key: 3624334
• MDR Text Key: 4136268
• Report Number: MW5034337
• Device Sequence Number: 1
• Product Code: IKZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTOPRONE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 103