MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. CONTOURA 1000/1000

Model Number C1000

Device Problem Entrapment of Device (1212)

Patient Problems Bruise/Contusion (1754); Physical Entrapment (2327)

Event Date 04/09/2014

Event Type  Other  

Event Description

It has been indicated by the customer that a caregiver sustained an injury to her fingers when they got trapped in the release handle for the safety sides on the contoura 100 model.The caregiver was putting the safety sides back in place and had pulled the release handle which is connected with the bed, locked, and trapped her fingers causing injury.

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for contoura 1000/1080 beds, we have not been able to identify any incident with similar fault description compared to the situation investigated here: finger entrapment during operating the safety side panels.There is no trend observed for reportable complaints with this failure mode.Taking into consideration that over 1900 contoura 1000/1080 beds with rails safety side have been sold since 2001, the complaint ratio is considered to be low - the failure rate for events with finger entrapment during operating the side rails is equal to (b)(4).One of the features of the contoura 1000/1080 bed are adjustable safety sides which can be inclined outwards at the top in order to increase the in-bed width or moved to the upright condition for transport.When sides are upright, the bed will pass comfortably through a 120 cm opening.In order to reduce the in-bed width, the release handle (located underneath the bed's mattress platform in the area of the knee/brake section) should be lifted and the side rails will swing up until the mechanism locks in the upright position.Based on the info collected to date, provided problem description, photographic evidence and conducted tests, it would appear that the nurse has placed her fingers between the release lever of the safety side and the part of the side rail assembly (nut covering the washer and screw); therefore, when she lifted the lever her fingers became trapped.The safety side's release handle is an "l" shaped tube.On the shorter part (parallel to the bed frame) is assembled blue dip moulding.This section should be used for lifting the release lever and adjusting the safety side.When the operator of the device, during increasing or reducing the in-bed width, is keeping all fingers on the release lever's moulding, there is no risk of entrapment.Nevertheless, if the operator would keep thumb on perpendicular part of the release lever, the entrapment between it and rigid part of the safety side assembly might occur.During an attempt to recreate the event, we (arjohuntleigh) have found that when the side rails are in incline position, the operator needs to fully extend an arm in order to grab the release handle.The part of the handle which is closest to the operator is the one covered by the blue moulding.When the side rail is in incline position, it is difficult to hold the handle at the area not covered by moulding and lift it.Additionally, in accordance with the product instructions for use (#746-128_04), which was provided to the customer together with the device involved in this event, in section 4 (operation) the user is advised to check that no obstacles such as bed-side furniture are in bed's path when it is operated.It is also advised that patient and caregiver limbs not be trapped.In summary, the device met its specifications, was being used at the time of the event by the caregiver (the device wa snot used for either patient treatment or diagnosis), and no serious injuries were sustained.Given the circumstances and the number of products in the market, this incident appears to be an isolated issue.We shall continue to monitor for any further events of this nature and do not propose any further action at this time.(b)(4).

• Brand Name: CONTOURA 1000/1000
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan 6205 2; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan 0000 6205; PL 000062052
• Manufacturer Contact: pamela wright ; 12625 westmore ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4001513
• MDR Text Key: 4773264
• Report Number: 3007420694-2014-00067
• Device Sequence Number: 1
• Product Code: OSI
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C1000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2014
• Distributor Facility Aware Date: 05/07/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2014
• Date Manufacturer Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2007
• 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