MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB CONCERTO/BASIC; LIFT, PATIENT, NON-AC-POWERED

Model Number BAB1000-01

Device Problems Component Falling (1105); Fracture (1260)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 05/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjo hospital equipment ab (under registration #(b)(4)).As of 2014 that number was de-activated due to the site no longer being a manufacturer and shipping product to the usa.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4).Additional information will be provided upon the investigation conclusions.

Event Description

Arjo was notified about an incident with involvement of concerto shower trolley, where it was reported that during hygienic activity, the stretcher tilted causing the fall of the patient from the lift.The involved patient sustained decomposed fracture sub trochanteric, compound fracture between the spine and the scapular coracoid process and cortical irregularity also at the distal end of the clavicle.The patient was hospitalized.The involved device was taken out of use.

Manufacturer Narrative

Arjo was notified about an incident with involvement of the concerto/basic shower trolley, where it was reported that during hygienic activity with resident, the stretcher tilted causing fall of the resident from the trolley.The involved resident sustained decomposed fracture sub trochanteric, compound fracture between the spine and the scapular coracoid process and cortical irregularity also at the distal end of the clavicle.The resident was hospitalized, but no further information about a treatment was provided.The involved device was taken out of use until inspected by qualified personnel.The review of similar reportable events with the involvement of the concerto/basic shower trolley in last years, revealed a low number of similar events.The arjo representative performed a technical evaluation of the device concerned and interview with the customer facility representative.The concerto/basic fiberglass stretcher is attached to the metal frame by eight bolts - four on both head and foot sides of the stretcher.The inspection of shower trolley's visual condition revealed that at the head end of the lift two bolts connecting stretcher with frame came out of the stretcher and other two were just about to lost connection with it.The stretcher was also cracked in places where these bolts were screwed.The lift condition did not allow to put it back to use.The customer facility was provided with training regarding the device usage on (b)(6) 2009 when lift was delivered.The involved concerto shower trolley at the time of the event was not under the arjo service contract as it expired on 2017-dec-31.Last maintenance was carried out on 2017-apr-13 by arjo and based on the date of the last service, next annual preventive maintenance should be scheduled on april 2018, however it was not carried out by arjo.According to the preventive maintenance report from april 2017 the unit was inspected, tested and left in full functional condition.According to section "care and maintenance" of the concerto/basic operating and product care instructions [04.Ba.05-2gb issued in june 2007] delivered with this device the customer obligation is to follow the preventive maintenance schedule on daily and weekly basis.Based on this manual caregiver should perform a check of the mechanical parts under the stretcher including bolts connecting stretcher with frame: "check mechanical attachments (concerto): tilt the stretcher.When tilted check for cracks in the stretcher on the positions shown in the illustration." (p.18) the points of the stretcher and frame connection, which should be checked are marked on the supporting picture in the ifu.The concerto/basic shower trolley has to be serviced according to the preventive maintenance schedule (by a qualified personnel) every year.The involved lift was serviced by arjo according to the schedule a year before the incident, however the service contract expired and customer facility did not request for service.Based on the collected information the stretcher was probably damaged after the conducted annual maintenance procedure.Any malfunction should have been detected during routine checks or next preventive maintenance.From the information collected to date, we came to a conclusion that the most likely cause of the incident was incorrect maintenance and lack of a proper carefulness when inspecting the device prior to use.It seems that the failure to follow recommendations concerning device checks included in the device instructions for use was a primary cause of the event occurrence.If that element of use error was not in place, the event could probably have been prevented.In summary, the device was not up to manufacturer's specification during the event occurrence - the part of the stretcher was torn out, causing the stretcher to overturn.The device was used for patient hygiene at the time of the event and in that way it contributed to the incident.This complaint was decided to be reported to the competent authorities due to the resident fall resulting in serious injury occurrence.

• Brand Name: CONCERTO/BASIC
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• MDR Report Key: 7536962
• MDR Text Key: 109013673
• Report Number: 3007420694-2018-00112
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2018
• Distributor Facility Aware Date: 05/14/2018
• Device Age: 9 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/15/2018
• Date Manufacturer Received: 05/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 93 YR
• Patient Weight: 74