MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ROTOPRONE

Device Problem Insufficient Information (3190)

Patient Problems Complaint, Ill-Defined (2331); Injury (2348)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).This appears to be a "malfunction" type of event not because there was a technical malfunction of the device, but since due to a user error the device did not perform as intended.When reviewing similar reportable events for rotoprone, we have not found any event with similar fault description compared to the one investigated here: during maneuvering the device it ran over an operator foot.There is no trend observed for reportable complaints with this type of event for the rotoprone devices.Based on the collected info it seems that most likely the event is related to the operator's techniques (handling/maneuvering the device) rather than the device on its own - the device was moved from one location to another, during this operation the device ran over the caregiver foot.The device involved in the event was found to be to specification, no failure has been found.In summary, the device was not being used when the event occurred for a pt treatment (however, the device location was changed within the facility), it contributed to the event since it ran over the caregiver foot.Fortunately, no serious injury has been sustained.No failure had been found within the device.However, we have decided to report this event in an abundance of caution and to be transparent.Given the circumstances and the number of similar events, this incident appears to be an isolated one.We shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: ROTOPRONE
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: pamela wright ; 12625 wetmore rd; suite 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4433029
• MDR Text Key: 5420290
• Report Number: 3009988881-2015-00007
• 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
• Remedial Action: Inspection
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 01/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1