MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. ENTERPRISE 8000; FNL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/20/2014

Event Type  Injury  

Event Description

It has been claimed by the facility that their staff member injured their foot on the brake pedal of the bed: during an attempt to release the brake pedal in order to clean the area behind the bed, the operator's foot slipped from the right foot pedal causing the foot instep injury and fracture of the metatarsal bone.The injured person was submitted to treatment and diagnosis to the physiotherapy dept on (b)(6) 2014.No further info about the caregiver outcome and applied treatment has been provided.An arjohuntleigh rep visited the facility in order to inspect the bed, unfortunately it was not possible to identify the actual bed involved in this incident due to the passage of time (event occurred on (b)(6) 2014, while the arjohuntleigh became aware of it on 02/2015).

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for enterprise range, we have not found another event with similar fault description compared to the one investigated here: concerning foot injury during using the bed's brake.There is no trend observed for reportable complaints with this type of event for the enterprise range.Unfortunately, without having detailed description of what occurred or with out device evaluation, we are left to review the limited info received from the customer per our best efforts, and compare it to our product knowledge.All enterprise 8000x beds are assembled in accordance to current work instruction and checked by qualified inspectors in accordance to quality procedures, before they are cleared for dispatch.Inspection procedure requires to check the functionality of castors and brakes on 100% of the manufactured beds.Devices must be in full working condition in order to pass the test and be cleared for dispatch.Based on the info collected to date, it seems that the operator's foot slipped from the brake during an attempt to release it.Unfortunately it is unclear how this resulted in the fracture of the metatarsal, there is no info confirming that the foot hit any object which could lead to this outcome.It could also not be confirmed whether the brakes were stiff to operate as indicated by the customer or not, as the device was not available for this inspection.Please note the enterprise 8000x have been designed and meet the requirements of the standard en 60601-2-52, clause bb.3.4.3 regarding the static force required to operate the brake pedal which shall not exceed the maximum 300 n allowed with the safe working load applied on the mattress platform.Additionally, the product instruction for use (e.G.#746-585-uk_03) which is delivered to the customer with each bed described the functionality fo the braking/steering system and warn the user to: see scanned page.The product instruction for use was not available at the facility during an arjohuntleigh rep visit, therefore we would recommend to provide to the customer current revision of the device labeling.In summary, despite our best efforts, the device evaluation was not possible, and we are unable to decide whether the device failed to meet its specifications, however it was being used at the time of event (attempt of the operator to release the brakes, no info about patient involvement) and therefore played a role in it.Unfortunately the operator of the device suffered an injury - fracture of the metatarsal.Given the limited info provided 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: ENTERPRISE 8000
• Type of Device: FNL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4589758
• MDR Text Key: 21085773
• Report Number: 3007420694-2015-00053
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/06/2015,02/06/2015

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: Other
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2015
• Distributor Facility Aware Date: 02/06/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2015
• Initial Date Manufacturer Received: 02/06/2015
• Initial Date FDA Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other