MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z.O.O. ACCESSORIES - MEDICAL BEDS; LIFTING POLE

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 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 patient in moving or turning on the bed, or when entering and leaving the bed; we have found some cases with a similar fault description to the one investigated here: breakage of the adjustable strap and handle manufactured by (b)(6).Previously, a similar issue with the adjustable strap and handle - then manufactured by another company: (b)(6) - has been the subject of a corrective field action by this supplier and in (b)(6) of 2010 we have issued (b)(6) 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.(b)(6) 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 information collected to date, provided problem description and photographic evidence, it has been found 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 came under load, fortunately there was no patient injury, no medical intervention being necessary.The defective adjustable strap has the tractability mark showing that it has been manufactured on jun 2007, making the item more than 8 years old at the time of the event ((b)(6) 2015).It has been indicated that when the event occurred the patient was on the contoura 480 device.The instruction for use (e.G.(b)(4)), which is supplied with each contoura 480 includes the list of the accessories suitable to be used with this device.Two types of lifting pole are mentioned on that list - multi-position lifting pole and lifting pole.Further review of the labeling provided to the customer together with these accessories, revealed that both of them are having the standard strap and handle - in which in order to adjust the length of the strap the buckle need to be manually adjusted on the strap.In the complaint at hand, the claimed strap was an adjustable strap and handle - in order to adjust the length it is enough to press the button and allow the strap to retract back into the handle.Therefore it has been concluded that the handle which broke was not the one which was originally provided with the lifting pole, and found to be suitable to be used with device involved in the event.Unfortunately, it remains also unknown which lifting pole was used at the time of event (e.G.If it was single-position lifting pole or three-position lifting pole).Review of the accessory user instruction (e.G.#(b)(4)), which is supplied with different models of lifting pole, suitable to be use with some of the contoura range beds, revealed that the following information are provided to the user: warning: refer to the bed user manual to confirm compatibility with these accessories.Warning: do not exceed the safe working load of (b)(4)kg.Additionally, review of the technical drawing of the lifting poles' models listed in the user instruction (#(b)(4)) as suitable to be use with some models of contoura beds, revealed that on each lifting pole's tube there is a label indicating that the safe working load (swl) is equal to (b)(4)kg.At the time of event the adjustable strap and handle was used with the patient weighing (b)(6) kg - exceeding the defined swl and overloading the part.Subsequently the item broke under the load.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 for signs of damage, fraying or loose stitching.The strap and handle shall be replaces if either is found to be faulty.Unfortunately, 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 - both for the device and accessory, 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 patient 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 overloading the strap and prolonged use.Given the outcome of our investigation we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

It has been claimed by the customer that the patient was using the adjustable strap and handle during the self-transfer from the bed to a commode and back to the bed.While returning to the bed, the plastic section of the handle broke.At that time, the patient was already over a mattress.Additionally provided description revealed that during the transfer back to the bed, patient has lifted his right leg on to the bed, had both hands on the monkey pole handle to pull himself up - at this point he was using his left leg to push off the floor to transfer back to bed.As he was holding the handle he started to move on to the bed - at that time the adjustable strap and handle broke at the area of the plastic housing, resulting in the patient falling back on the mattress placed on the bed.The commode was placed on the left side of the bed and the lifting pole with adjustable strap and handle was fitted on the right hand side of bed.There were no injuries sustained.The patient involved in the event is a (b)(6) years old male (weight (b)(6) kg).The bed and the lifting pole which were used at the time of event was not available for the inspection as it was used by another patient.Inspection of the handle revealed that it seemed to be in fair condition before the incident.

• Brand Name: ACCESSORIES - MEDICAL BEDS
• Type of Device: LIFTING POLE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z.O.O.; ul. ks. wawrzyniaka 2; komorniki, PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z.O.O.; ul. ks. wawrzyniaka 2; komorniki, PL-62 052; PL PL-62052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5229129
• MDR Text Key: 31794472
• Report Number: 3007420694-2015-00213
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/17/2015,10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2015
• Distributor Facility Aware Date: 10/21/2015
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2015
• 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: 58 YR
• Patient Weight: 90