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

Model Number	BAB1103-01
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Arjo was notified by health canada of an incident related to the concerto shower trolley.It was indicated that a patient fell from the device as the lock failed.No injuries were reported.The device was inspected by an arjo service technician.The inspection revealed that the concerto locking mechanism can be locked and unlocked correctly.No malfunction was found.There was not possible to confirm the customer allegation.The arjo service technician cleaned and lubricated the locking mechanism and pivot mechanism.
Additional Manufacturer Narrative
Process of analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.
Additional Manufacturer Narrative
Arjo was notified by health canada of an incident related to the concerto shower trolley.It was indicated that a patient fell from the device as the lock failed.Initially, no injuries were reported.After contacting the facility, it was indicated that the concerto's side support had unlocked, and the patient had fallen off the device, suffering bruises.Concerto/basic shower trolley is intended for bathing and showering in hospitals or care facilities residents under the supervision of trained skilled nursing staff.The device is equipped with two side supports located on each side.In order to release it from the up position the two catches need to be pressed at the same time.When raising the side support, the two catches shall be snapped 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 instruction for use (ifu;04.Ba.05_19).The ifu guides through using the side support: "when raising the side support, make sure the two catches snap into place." "warning: to avoid patient falling out of the device, make sure that all side supports are in a locked position." during the device inspection, it was not possible to recreate the alleged scenario.The device functioned as intended.The side support locking mechanism locked and unlocked correctly.Therefore, it seems that the side support was not locked and not checked to be in locked position during use.In conclusion, the device was used for a patient handling at the time of event, and in that way contributed to the event.No device malfunction was detected upon the evaluation performed, therefore the device met all manufacturer¿s technical specifications.However, as per the customer¿s allegation the side support unlocked, so the device did not perform as intended.The complaint decided to be reportable due to the patient's fall resulting in a minor injury.
Additional Manufacturer Narrative
After contacting the facility, arjo was informed that the concerto side support unlocked and the patient fell from the device.Initially, no injuries were reported as a consequence.However, after receiving additional information from the facility, it was indicated that the patient had suffered bruising as a result of the fall.Process of analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

• 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
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17507770
• Report Number: 3007420694-2023-00188
• Device Sequence Number: 20408924
• Product Code: FSA
• UDI-Device Identifier: 05055982796163
• UDI-Public: (01)05055982796163(11)220927
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: BAB1103-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 07/18/2023; 07/18/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/07/2023; 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown