MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. MINUET

Device Problems Kinked (1339); Device Maintenance Issue (1379); Unintended System Motion (1430)

Patient Problems Bruise/Contusion (1754); Contusion (1787)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for minuet 2 beds, we have not found any case with a similar fault description compared to the one investigated here: non-patient trapping their fingers in a gap created between the bowed wooden top panel and the top of the head/foot end fabrication of the bed.There is not trend observed for reportable complaint with this failure mode for minuet range beds.Taking into consideration that over (b)(4) minuet 2 have been sold since 2004, the complaint ratio is considered to be low - the failure rate for this event is less than (b)(4).The device was inspected by an arjohuntleigh rep at the customer site who found out that the wooded top panel has been pushed up by the plastic telescopic guide bush because it had become dislodged from the inner tele tube and as the bed was lowered it has bowed the wooden top panel.When the maintenance man touched the panel the guide bush has re-seated into the tele tube snapping the gap shut caused by the guide bush.The issue with the top caps being pushed out of the inned after repeated raises/lower operations, causing the end panel to rock from side to side is known to the arjohuntleigh since the end of 2008 and has been already addressed.Except this particular event, all issues related to this malfunction were concerning noisy, rocking of the bed from side to side, which caused discomfort, annoyance and/or inconvenience to the patient - to date, no events were reported to us where there was an actual adverse outcome involving injuries.The product instructions for use (e.G.#746-396_11) which are supplied together with each device, inform the user in section 8.Care and preventive maintenance, that in order to ensure that the device continues to preform within its original specification; the preventive maintenance procedure should be carried out at least annually.Unfortunately, as we have not received any service / maintenance history against this referenced complaint, we are not in a position to determine if the adequate preventative maintenance was performed on this in accordance with our recommendations.Additionally, the product instructions for use include a warning that the preventive maintenance must be carried out by suitable trained and qualified personnel, as failure of do so may result in injury or an unsafe product.As the maintenance man who suffered the injury was a 3rd party person, it is unknown if he was appropriately trained.At the request of the customer, arjohutleigh is providing a service manuel,, which is intended to be used by arjohuntleigh approved service technicians, also inform the customer that in no event will arjohuntleigh be responsible for any service or repair undertaken by customer or third parties.Therefore, we would recommend to info the facility about the findings of our investigation and advice to have the suitable trained and qualified personnel conducting the maintenance procedure.In summary, the device failed to meet its spec, at the time of the event was under maintenance procedure and contribute to the outcome: non-pt finger entrapment.Given the circumstances and the number of products in the market this incident appears to be isolated issue.We shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: MINUET
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787000
• MDR Report Key: 3659349
• MDR Text Key: 4197183
• Report Number: 3007420694-2014-00008
• Device Sequence Number: 1
• Product Code: LLI
• 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

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 01/08/2014
• 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