MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CONCERTO + BASIC; LIFT, PATIENT, NON-AC-POWERED

Model Number	BAB1000-01
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Codes	Limb Fracture (4518); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was evaluated by the arjo representative.The shower trolley was found to be with no unexpected damage or deficiencies.The side rails where tested and found without any issue.The investigation is on-going and further information will be provided in the next report.
Event or Problem Description
Arjo was informed about an incident with involvement of a concerto shower trolley.It was reported that the resident fell out on the floor, when the side support unlocked and moved to lower position.The patient was in pain, had a swollen knee and was taken to the emergency room for an x-ray.It was confirmed that patient sustained the femoral fracture.
Additional Manufacturer Narrative
Arjo was informed about an incident with involvement of a concerto shower trolley.It was reported that the resident fell out on the floor, when the side support unlocked and moved to lower position.The patient was first in the emergency room for an x-ray.Then had a swollen knee, which got worse and hospital care for a patient was needed.It was confirmed that the patient sustained a femoral fracture.The device was evaluated by the arjo representative.The shower trolley was found to be with no damage or deficiencies.There were no visible damages or cracks on the device, that would indicate the side gate was opened or loosened by itself.The side support were not damaged, the safety catches were intact and locking as required.The foot end support was found mounted downwards.The technician attempted to open the locked side supports, but they remained closed.Even with one safety catch loosened, the side support did not unlock.Each concerto unit is equipped with two side rails (one on both sides of the trolley) and with four safety catches (two on each side support).The side support is lowered by pressing the two catches at the same time.When raising the side supports, user should make sure that the two catches snap into place.The concerto/basic must be used by appropriately trained caregivers with adequate knowledge of the care environment its common practices, procedures and guidelines in the instructions for use (ifu; 04.Ba.05_17).Ifu recommends user to perform resident assessment according to the specified criteria, such as to use this equipment mainly with resident that is almost completely bedridden and totally dependent.If criteria listed in the ifu are not met an alternative equipment should be used.Ifu also provides other information for safe and correct use of the device e.G.: ¿to avoid injury, make sure the resident is not left unattended at any time.¿ ¿to avoid residents from falling out of the device, make sure that all side supports are in locked position.¿ ¿to avoid falling, make sure that the resident is positioned in accordance with these instructions for use.¿ based on the collected information, the root cause of the investigated incident could not have been identified as the alleged malfunction (unlock of the side support) was not possible to be recreated during evaluation and no other issue that could have contributed to the incident was detected.In conclusion, the device was used for patient handling at the time of incident occurrence and in that way contributed to the event.No device malfunction was detected upon the evaluation conducted after the event, therefore the device was considered according to the manufacturer¿s technical specification.However, as per the customer¿s allegation it unlocked, so the device did not perform as intended.This complaint was decided to be reported to the competent authorities due to indication of the patient fall which resulted in a serious injury.

• Brand Name: CONCERTO + BASIC
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• MDR Report Key: 12224653
• Report Number: 3007420694-2021-00106
• Device Sequence Number: 5061370
• Product Code: FSA
• UDI-Device Identifier: 05055982788083
• UDI-Public: (01)05055982788083(11)201118
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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
• Operator of Device: Other
• Device Model Number: BAB1000-01
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 07/26/2021
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention