MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ROTOREST MODEL (IV) ETHOS; NONE

Model Number 8259965-R

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Fall (1848)

Event Date 11/19/2014

Event Type  Death  

Event Description

It has been claimed that during nursing activities, the intubated and ventilated patient fell out from the rotorest device.In accordance to the information from the facility, the nurse did all necessary preparations for the activities, he turned the frame manually into horizontal position and fully locked the bed (the message 'bed locked' was shown on the display).In order to gain the access to the patient, the support pads were removed.At that time the bed started to turn and as a result the unsecured patient fell on the floor.On (b)(6) 2014 arjohuntleigh received information that the patient involved in the event died.

Manufacturer Narrative

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site kinetics concept inc.From november 2012 thru october 31, 2014 medwatch reports related to complaints of this product were submitted under registration #3010048749 - as this registration number is no longer valid, reports related to complaints of this product will be submitted under registration #3009988881.Additional information will be provided upon conclusion of the investigation.

• Brand Name: ROTOREST MODEL (IV) ETHOS
• Type of Device: NONE
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 4958 stout dr.; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 4958 stout dr.; san antonio TX 78219
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4377479
• MDR Text Key: 5237949
• Report Number: 3009988881-2014-00001
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8259965-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2014
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death