MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. FIRST STEP SELECT

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 05/01/2014

Event Type  Injury  

Event Description

The following was reported to arjohuntleigh by the nurse: on (b)(6) 2014, the nurse was turning and bathing the patient.The patient's feet slipped from the surface of the bed and the nurse was unable to get the patient back into the bed.The patient subsequently fell out of the bed onto the floor.On (b)(6) 2014, i spoke with the director of nursing (b)(6) who reported that the patient exit was due to user error.The nurse taking care of the patient had the overlay on insta-flate while doing personal care on the patient.The patient was in a vegetative state, very contracted with a long history of osteoporosis.The patient slipped and the nurse was unable to keep the patient in bed.The patient fell and x-rays determined that she broke both ankles.The current status of the patient is 2 healing fractures of the ankles and is reported to be in stable condition.The overlay was removed from the bed and the (b)(4) reported that the serial number was not noted and the facility is unable to determine which overlay the patient had been on.If additional information regarding the serial number becomes available a supplemental report will be issued.

Manufacturer Narrative

This report is being filed by the manufacturer arjohuntleigh, inc.Please note that previous medwatch reports for this product may have been submitted from the manufacturing site kinetic concepts inc.As of (b)(4) 2012, complaints related to this product are to be handled by arjohuntleigh, inc.Based on the information provided, product's serial number was not identified and therefore was not returned for evaluation.If additional information becomes available a supplemental report will be issued.

• Brand Name: FIRST STEP SELECT
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 12625 wetmore road; suite 308; san antonio TX 78247
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 42625 wetmore road; suite 308; san antonio TX 78247
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste. 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3827844
• MDR Text Key: 4498610
• Report Number: 3010048749-2014-00075
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/01/2014

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2014
• Initial Date FDA Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 80 YR
• Patient Weight: 91