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

Model Number 161AA4A1A

Device Problems Detachment Of Device Component (1104); Device Issue (2379)

Patient Problem Bruise/Contusion (1754)

Event Date 02/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided following the conclusion of the manufacturer's investigation.

Event Description

On (b)(6) 2016 arjohuntleigh has been informed about the following incident: whilst moving in bed the patient reached up for the grab handle and when he put his weight on it, trying to pull himself up, the grab handle broke and detached.Patient was rapidly moved downward and his elbow struck the handrail.As a consequence the client sustained bruise to his elbow.

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 couple cases concerning the breakage of the adjustable handle, however they were related to breakage of the retraction mechanism.Previously, a similar issue with the adjustable strap and handle manufactured by company rolko - has been the subject of a corrective field action.In june of 2010 we have issued an fsn : san 01 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 january 2007 and january 2009.Based on the information collected to date, provided problem description and photographic evidence, it has been found that the adjustable strap and handle which has been involved in the event has been supplied by former supplier (b)(4) and falls into the scope of the referenced fsn.The break has occurred as the handle came under load, fortunately the incident resulted in patient minor injury.The defective adjustable strap has the tractability mark showing that it has been manufactured on april 2007, making the item almost 9 years old at the time of the event ((b)(6) 2016).It has been indicated that when the event occurred the patient was on the minuet bed.The instruction for use (746_396_uk_6), which is supplied with each minuet 2 includes the list of the accessories suitable to be used with this device.According to mentioned document the handle and strap should be examine for sign of damage, fraying or loose stitching.Strap and handle should be replaced if either are faulty.The failure/breakage of adjustable strap and handle is visually detectable before use: even more so, since the instruction for use of the device identifies the issue using the safety warning or recommendation.Moreover this particular device appears to have been in use outside of the recommended operational life of the strap and handle what could enhance the occurrence of failure.Additionally, the instruction for use (746-549_1) indicates that the lifting pole should not be loaded with more than 75kg.Given weight is the maximum safely support load.It is known from incident description form prepared afterwards that the patient weight was more than recommended ((b)(6)).The adjustable strap and handle (part 805.855) has already been replaced according to the field action plan therefore no further suggestions are needed.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.With all information stated above, it appears that this event occurred due to the combination of handle design flaw and exceeding the swl of the part.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.

• Brand Name: MINUET
• Type of Device: MINUET
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5516777
• MDR Text Key: 40941846
• Report Number: 3007420694-2016-00036
• 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: company representative,consum
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 04/27/2016,02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 161AA4A1A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2016
• Distributor Facility Aware Date: 02/24/2016
• Event Location: Home
• Date Report to Manufacturer: 03/22/2016
• Date Manufacturer Received: 02/24/2016
• 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: 62 YR
• Patient Weight: 146