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

Device Problems Detachment Of Device Component (1104); Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product involved in the incident is the contoura bed used with an adjustable strap and handle which is a part of lifting pole.The accessory is intended to assist the patient in moving or turning on the bed, or when entering and leaving the bed.Lifting poles are supplied complete with an adjustable strap and handle.On (b)(4) 2017 arjohuntleigh has been informed that the strap and handle used with contoura bed broke while being in use with patient (male of average build).No injury was reported as a result of this incident.From additional information provided we have been able to confirm that adjustable strap & handle used while the event occurred was manufactured in october 2007 by the arjohuntleigh supplier -(b)(4).Photographic evidence provided by the arjohuntleigh representative allowed us to confirm the alleged issue - breakage of the handle in the area of the retraction mechanism.It needs to be emphasize that in order to reduce the risk of using defective/damage adjustable strap and handle even further, instruction for use supplied together with contoura bed- in section care and preventive maintenance - informs the user that lifting pole strap and handle needs to be examined every 12 months for any signs of damage, frying or loose stitching and warns to replace the strap and handle if either are faulty.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.Moreover we cannot confirm if the device was overloaded as the patient weight remained unknown.Taking into consideration fact that the accessory has been in use for over 9,5 years at the time of the incident it appears most likely that this particular failure is the result of prolonged use.In summary the device that 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.No injury was sustained as a result of this event, however having in mind former history of the complaints related to adjustable strap and handle it has been decided to report this event based on the potential of harm upon recurrence.Based on the collected information and findings made during the inspection of the involved device it can be assumed that this particular failure is the most likely the result of prolonged use.Compared to the amount of sold devices and in comparison to their daily use the occurrence rate of reportable complaints with this failure is relatively low.

Event Description

On (b)(4) 2017 arjohuntleigh has been informed that the strap and handle used with contoura bed broke while being in use.Photographic evidence provided by the arjohuntleigh representative allowed us to confirm the alleged issue - breakage of the handle in the area of the retraction mechanism.No injury was reported as a result of this incident.

• Brand Name: ACCESSORIES - MEDICAL BEDS
• Type of Device: ACCESSORIES - MEDICAL BEDS
• 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; 62-05 2; PL 62-052
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; PL 62-052
• MDR Report Key: 6709795
• MDR Text Key: 80030073
• Report Number: 3007420694-2017-00157
• 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,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• 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: 07/13/2017
• Distributor Facility Aware Date: 06/19/2017
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2017
• Date Manufacturer Received: 06/19/2017
• 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