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

Model Number 8259965-R

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015 it has been claimed by the customer that the leg flap was opened by the facility staff in order to have a better access to the pts' leg for washing activities.When the flap was about to close, the locking mechanism came off.There were no injuries sustained by the caregiver or pt as a result of the event.

• Brand Name: ROTOREST MODEL (IV) ETHOS
• Type of Device: NONE
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• Manufacturer Contact: 50 north gary ave., suite a; roselle, IL 60172-1684
• MDR Report Key: 4536718
• MDR Text Key: 5540771
• Report Number: 1419652-2015-00057
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2015

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: Other
• Device Model Number: 8259965-R
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other