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

Model Number BAB1000-01

Device Problem Device Handling Problem (3265)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/03/2019

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2019 arjo representative was informed about the incident involving concerto + basic.It was reported that during patient showering the stretcher of the concerto basic shower trolley turned over and tilted leading to patient's fall from the device.As a result of the incident, the patient (female, (b)(6) years old, (b)(6)) sustained nasal septum fracture and other facial fractures.Concerto + basic is a hydraulic shower trolley that serves as assistance during patient hygiene care, showering and bathing.The device is intended for indoor use.The device functions are: manual raising and lowering, straight steering, horizontal lock and tilt stretcher function.The last function makes the stretcher tilt to side or reverse trendelenburg position to help with care or cleaning and disinfection of the equipment.By doing so button from the tilting mechanism located under the stretcher must be pressed, then the catch is moved to one side.Closing should be done by snapping the stretcher onto the place.Clicking noise is heard when the stretcher is closed.After the event, the device was inspected by arjo representative who stated that it was in good condition, with all functions working correctly.There were no damaged parts nor malfunction found with the involved device.For this reason mechanical failure of tilting mechanism is not considered as a possible contributing factor.The description of the event circumstances , collected upon arjo visit at the customer facility were presented as following "no malfunction or damaged parts.Wrong utilization performed by the caregivers." taking this opinion into account, the most likely scenario of events preceding this incident is that the caregivers have tilted the stretcher by unlocking the lever for cleaning purposes and forgotten to lock the stretcher after cleaning.It needs to be pointed out that caregivers were aware that the security check of the lock before using it with patient was not performed.In the instruction for use for concerto/basic (04.Ba.05_4gb) there are instructions and warnings for the caregivers, which include: "the stretcher can be tilted to help with cleaning and disinfection.This operation is easier done with brakes applied.The tilting mechanism is located under the stretcher.1) press the button, then move the catch to one side.2) tilt the stretcher." "make sure that the catch has locked (click sound) the stretcher after putting it back in place to prevent tipping.Tipping can cause bodily injury to both the resident and the caregiver." based on all information gathered we came to conclusion that not locking the stretcher could have directly contributed to the event of patient drop.This could be a result of not following the device handling procedures as indicated in the instruction for use of the device.It was also confirmed that last training for the facility staff was provided in july 2012, 7 years ago.In summary, arjo device was used for resident handling when the event took place and therefore played role in the incident.No technical deficiency was found, however the shower trolley titled and from that perspective did not perform as intended at the time of event.We report this event to competent authorities due to indication of patient fall and an injury occurrence.

Event Description

On (b)(6) 2019 arjo representative was informed about the incident involving concerto + basic.It was reported that during patient showering the stretcher of the concerto basic shower trolley turned over and tilted leading to patient's fall from the device.As a result of the incident, the patient sustained nasal septum fracture and other facial fractures.

Manufacturer Narrative

This is a follow-up report for the initial report sent on 2019-aug-01.Please note that section h10 has been updated and proper exemption statement for legacy products has been added: please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjo hospital equipment ab (under registration #9611530).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 not to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration #3007420694.

• 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: 8850412
• MDR Text Key: 152990166
• Report Number: 3007420694-2019-00121
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: BAB1000-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 07/03/2019
• Supplement Dates FDA Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 94 YR
• Patient Weight: 70