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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

(b)(4).

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 medwatch reports related to complaints to this product will be submitted under registration number.When reviewing similar reportable events for rotorest, rotorestmi/ethos and rotorest delta therapy system, we have not been able to found any similar fault description compared to the situation investigated here: hatch's detent coming off.There is no trend observed for reportable complaints with this failure for rotorest ethos.The product involved in the incident is a rotorest ethos; model number 8259965-r, serial number: (b)(4).The device is part of the arjohuntleigh (b)(4) rental fleet and was rented to the (b)(6) ((b)(6)) on (b)(6) 2015.The device involved in the event is in the (b)(4) rental fleet since (b)(6) 2007-making in at least 7 years old at the time of the event.It is also worth noting that we are not aware of any other problems claimed by the customer with the device prior to the incident.Based on the collected info, we have been able to establish that the locking mechanism fell off from the hatch, when the caregiver was trying to close the hatch after washing the pt.The operator of the device was fully aware of the issue and raised the complaint.Inspection of the device conducted by an arjohuntleigh representative revealed that the detent's mechanism was assembled on the hatch with use of 3 original screws and one bigger screw.The holes on hatch showed sign of wear.It seems most likely that before releasing the device to the customer, the detent has been disassembled in order to clean/disinfect the hatch and has not been screwed in properly.It is also possible that during one of the former device rental periods, the customer conducted a repair and assembled the detent with use of a different screw.Usage of a bigger screw can cause damage to the hole in the hatch which then would not be holding the screw tight.Unfortunately, we are unable to determine when and by whom the bigger screw was implemented.No other or related complaints were received on this issue, there does not appear to be reason to assume this was anything else than a one-off error.The rental centre employees responsible for the maintenance and inspection of the device before renting them further are going to be made aware of this particular issue and reminded about need of proper assembly of the detent and using only compatible parts.In summary, the device failed to meet its specification, was being used at the time of the event for pt treatment, and due to this played a role in the incident.Fortunately, there were no injuries sustained.Given the circumstances and the fact that 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: ROTOREST MODEL (IV) ETHOS
• Type of Device: NONE
• 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 ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4536813
• MDR Text Key: 18651730
• Report Number: 3009988881-2015-00010
• 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: Repair
• Type of Report: Initial

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 01/26/2015
• Initial Date FDA Received: 02/19/2015
• 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