MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 8000

Model Number ENTERPRISE LIFTING POLE AND HANDLE

Device Problems Break (1069); Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2015

Event Type  malfunction  

Event Description

It has been claimed by the customer that when the pt was attempting to lift himself off the bed to adjust clothing with assistance of the nursing staff, the severe pain occurred in his operated leg, causing him to grip and pull down sharply the adjustable strap and handle.This has caused it to break - the metal coil spring out.Fortunately pt has not been injured.

Manufacturer Narrative

This report is being filed under exemption (b)(4) by arjohuntleigh (b)(6) on behalf of the importer arjohuntleigh, inc.(b)(6) when reviewing similar reportable events involving the adjustable strap and handle which is a component part of the optional lifting pole accessory - intended to assist a pt in moving or turning on the bed, or when entering and leaving the bed; we have found 6 cases with a similar fault description to the one investigated here: breakage of the adjustable strap and handle manufactured by van riesen.Previously, a similar issue with the adjustable strap and handle - then manufactured by another company: rolko - has been the subject of a corrective field action by this supplier and in (b)(6) 2010 we have issued 2010 following a notification from the supplier that a review of the performance of the strap and handle products had identified a risk that part of the strap retracting mechanism may break whilst in use.Rolko at the time advised the potentially defective parts were produced between (b)(6) 2007 and (b)(6) 2009.The particular adjustable handle, which is related to this event does not fall within the scope of this action - as it has been manufactured by another supplier.Based on the info collected to date, provided problem description and photographic evidence, it has been found out that the actual piece that has broken is the belt retractor housing which provides the adjustment of the strap.The break has occurred as the handle come under load, fortunately there was no pt injury, no med intervention being necessary.The defective adjustable strap has the tractability mark showing that it has been manufactured on 07/2008, making the item more than six years old at the time of the event ((b)(6) 2015).Accessory instruction for use (e.G.(b)(4)), which is supplied with each lifting pole (ent acc01 and ent acc03), warn the user that the operational life of the strap and handle is two years when used and maintained in accordance with the manufacturer's instructions.After this time the complete unit should be replaced.Additionally, the strap and handle should be inspected regularly.If any sign of wear or damage is found, the user is to remove it from use immediately and replace the complete unit.In order to reduce the risk of using defective/damage adjustable strap and handle even further, each product's (with which the accessory can be used) instruction for use- in section care and preventive maintenance - informs the user that lifting pole strap and handle need to be examined daily and warn that failure to carry out these checks, or continuing to use the product if a fault is found, may compromise the safety of both the pt and carer/user.We have not received from the customer any service / maintenance history against the referenced complaint, so we are not in a position to determine if adequate preventative maintenance was performed in accordance with our recommendations.Therefore we would recommend to provide to the customer current revision of the instruction for use - especially the part about frequency and steps of preventive maintenance.In summary, the device failed to meet specifications, was being used at the time of the event for the pt treatment and therefore played a role in the event.Fortunately there is no record of any injury.This particular failure is most likely the result of prolonged use outside of the recommended operational life of the strap and handle.Given the outcome of our investigation we shall continue to monitor for any further events of this nature and not propose any further action at this time.Imp ref # (b)(4).

• Brand Name: ENTERPRISE 8000
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. wawrzyniaka 2; komorniki 6205 2; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. wawrzyniaka 2; komorniki 6205 2; PL 62052
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4536502
• MDR Text Key: 5518822
• Report Number: 3007420694-2015-00035
• Device Sequence Number: 1
• Product Code: FNL
• 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: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/16/2015,01/27/2015

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: Lay User/Patient
• Device Model Number: ENTERPRISE LIFTING POLE AND HANDLE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2015
• Distributor Facility Aware Date: 01/27/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2015
• Initial Date Manufacturer Received: 01/27/2015
• Initial Date FDA Received: 02/19/2015
• 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
• Patient Age: 59 YR
• Patient Weight: 82