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

Model Number BAB1101-01

Device Problem Device Handling Problem (3265)

Patient Problems Fall (1848); Hematoma (1884)

Event Date 08/04/2017

Event Type  malfunction  

Manufacturer Narrative

Concerto + basic is a hydraulic shower trolley that serves as assistance during patient hygiene care, showering and bathing of patients.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 to help with cleaning and disinfection of the equipment.By doing so a 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 on the place.The stretcher is closed when clicking noise is heard.In the reported complaint the allegation was that during patient treatment the stretcher of the concerto basic shower trolley tilted leading to patient's fall from the device.As a result of the incident, the patient (male) sustained hematoma on his head.No hospitalization has been mandatory.After the event, the device was inspected by arjohuntleigh representative who found it in good condition, with all functions working correctly.Safety locking system was perfectly functioning, it was possible to recreate the incident only with incorrectly engaged stretcher lock.For this reason failure of tilting mechanism can be excluded.It needs to be emphasized that before patient placement a caregiver shall ensure that all catches are locked in place in order to avoid patient fall.As per product instruction for use (04.Ba.05_12gb): "to avoid the patient from falling out of the device, make sure that all catches are in a locked position".No other complaint was registered to this device, which would suggest that no issue with the shower trolley was noticed by the customer during the everyday and every week check.Looking on the previous similar complaints 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 information provided by the customer confirm that the caregiver has not performed the security check of the lock before using it with patient.This could directly contribute to the reportable event as later in use the stretcher tilted with a patient on it.We see a direct causal link between not locking the stretcher and the drop.The device was inspected after the event and no failure was found, it worked as intended.Therefore, it appears from our evaluation that most likely a use error related to the failure to lock the stretcher caused the incident.This could be a result of staff incorrectly trained or not following the device handling procedures as indicated in the operating and maintenance instructions of the device.It was being used for patient handling at the time of the event and in that way contributed to the event.The received information and our evaluation as described above shows that if all the warnings and recommendations were followed in accordance to labelling, there would be no patient or caregiver at risk.

Event Description

Arjohuntleigh received a customer complaint where it was reported that the stretcher of the concerto basic shower trolley tilted and patient (male) fell on the floor.As a result, the patient sustained hematoma on his head.No hospitalization has been mandatory.

• 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
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 6837301
• MDR Text Key: 86304280
• Report Number: 3007420694-2017-00180
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BAB1101-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2017
• Distributor Facility Aware Date: 08/04/2017
• Device Age: 8 YR
• Event Location: Other
• Date Report to Manufacturer: 09/01/2017
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2009
• 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