MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CONCERTO + BASIC; FSA

Model Number BAB1000-01

Device Problem Device Handling Problem (3265)

Patient Problems Fall (1848); Injury (2348)

Event Date 09/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It was reported by the facility representative that during bathing, the caregiver rolled the resident on to her right side against the side rail and the rail gave away.This caused the resident to fall off the trolley on to one of the caregivers injuring her leg and ankle.The second caregiver was trying to reach over the trolley from the opposite side to help prevent from falling, and suffered injury to her shoulder.When reviewing similar reportable events for concerto+basic shower trolley, we have found a limited number of cases with similar fault description (side rails catches not performing as intended).(b)(4).The device was checked by arjohuntleigh representative visiting the site after event, who found that the mattress was starting to crack on the edges, it was not installed properly and interfering with the latch mechanism.In effect latch in the rear was holding but the latch in front was not.There are two points that influenced this incident occurrence.Incorrectly installed mattress, which made one catch impossible to close.The safety catches act as a locking mechanism of the side rails.There are two side rails on each device and on each side of the rail there are two safety catches.The mattress should be attached by placing the side straps around the edge of the stretcher, between the catches.When the mattress is attached to the stretcher properly, it still gives approximately two centimeters of space from each catch.The obstacle under the side rail is visually detectable before use: even more so, since the instruction for use of the device identifies the caregiver's obligation to check both safety catches using safety warnings: "fold down the side support by pressing the two catches at the same time.[.] when raising the side support, make sure the two catches snap into place." "warning: to avoid the patient from falling out of the device, make sure that all catches are in a locked position." moreover, functionality test (including catches on the side supports) should be performed by the caregiver every week.From the provided information, the catches were not checked if snapped into place.It is unknown since when the mattress was wrongly installed, making the catch impossible to lock - but it should be detected prior use and not used with the patient.Wrong resident's positioning.The instruction for use gives safety warnings concerning position of the patient."warning! to avoid falling, make sure that the resident is positioned in accordance with these instructions for use." the resident was positioned on the side of the stretcher and resisted on the safety side, what caused the wrongly attached catch to release.In normal use, with a correctly installed mattress, releasing the safety catch is not likely to take place.The following mitigating actions (referred to the instruction for use) need to be omitted by the device operator to arrive at a situation where a patient is at risk: the pre-use (during-use) checks performed according to the ifu, replacing safety catches every year according to preventive maintenance schedule, positioning the resident in the center of the stretcher.The failure mode at hand is in line with: not checking the device before use as well as not making sure the patient is positioned correctly on the device, therefore user error could not have been ruled out.Our investigation shows that if the ifu safety warnings are followed, it will not lead to any patient or caregiver risk.The device in question was up to manufacturer's specification except from the worn mattress cover which would not influence on the event.It was being used for patient handling at the time of the event and in that way played a role in the event outcome.

Event Description

It was reported by the facility representative that during bathing, the caregiver rolled the resident on to her right side against the side rail and the rail gave away.This caused the resident to fall off the trolley on to one of the caregivers injuring her leg and ankle.The second caregiver was trying to reach over the trolley from the opposite side to help prevent from falling, and suffered injury to her shoulder.Both caregivers were checked out by on site infirmary and released on modified duty.

• Brand Name: CONCERTO + BASIC
• Type of Device: FSA
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra 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: 6020903
• MDR Text Key: 57158140
• Report Number: 3007420694-2016-00210
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 10/12/2016,09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: BAB1000-01
• 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: 10/12/2016
• Distributor Facility Aware Date: 09/13/2016
• Device Age: 8 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/12/2016
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2016
• 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