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

Model Number BAB1000-01

Device Problem Bent (1059)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 08/25/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation to this complaint has been carried out and the results are following.It was reported by the customer haven of hope nursing home that the side rails of the arjohuntleigh concerto shower trolley suddenly opened during bathing and a patient (woman) slipped out of the bath trolley from the left side of device to the ground.Due to fall the resident had sustained head injury and was sent to the emergency room.The resident was not hospitalized, but further observation was needed of regard for patient age ((b)(6)).The shower trolley was inspected by arjohuntleigh representative who found that left side support does not meet its specification.The frame of the left side support was deformed and one out of two safety catch was out of place and could not be locked properly - it was hard to lock safety catch in place.Moreover, some scratches were found on the side support.Despite of the found damages, general device condition (including accessories and mattress) was good.The customer alleged that the catches were checked and locked prior the bathing as per instruction provided in user manual.It was not reported how exactly the fall occurred and customer did not confirm why the side support opened.It is unknown, whether the side support frame had been bent before or during the incident.With the limited information provided, however, we were able to list a few possible causes of reported issue: - the resident was leaned on the side support while being moved, what could be deemed as a use error against the product labeling, - side support frame could have been bent before use by frequent hitting any external object as bedroom space is limited (scratches on the side support were detected), - caregivers were not properly trained of the device usage and do not following ifu regarding verification of product performance or not checking correctly if the catches are locked in place before use.In normal use with a correctly functioning device, releasing the safety catch is not likely to take place.In accordance with the possible causes and factors listed above, instructions for use, which is delivered with every device, clearly describes how the device should be used: "warning! to avoid falling, make sure that the patient is positioned in accordance with this ifu." "side supports: fold down the side support by pressing the two catches at the same time.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." also, if the side rail had been bent and despite that used with the patient, it could influence problems with catches, therefore the product should have been withdrawn from use."action before the first use [.] 3.[.] if any part is missing or damaged - do not use the product!" when reviewing reportable events for concerto + basic shower trolley, we have found a limited number of complaints.The irregularity in receiving complaints with this failure mode is observed.When comparing over (b)(4) concerto and basic trolleys sold since 1999, to the number of complaints, the complaint ratio is considered to be low.In summary, with limited information provided, we were able to list several factors that can be considered as use errors, however since none of this has been confirmed by the customer, the exact root cause cannot be determined with certainty.Our investigation shows that if the ifu safety warnings are followed, it will not lead to any patient or caregiver risk.When the event occurred the device was use for patient hygiene and was directly involved in the reported incident.It failed to meet its performance specification as the side rail opened and a resident fall to the floor.We reported this incident due to patient fall and sustained injury assessed by arjohuntleigh clinical expert as a serious.

Event Description

Arjohuntleigh received customer complaint where it was reported that during bathing a patient (woman, weight (b)(6)) slipped out of the bath trolley from the left side of device to the ground.According to the customer, the left side support suddenly opened during bath, however the exact conditions of this event are unknown.The customer stated that safety catches were locked in place before bathing.Due to the fall the patient sustained head injury and was sent to an emergency room.The patient was not hospitalized, but further observation was needed of regard for patient age ((b)(6)).

• Brand Name: CONCERTO+BASIC
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. wawrzyniaka 2; komorniki, 62-05 2, P; PL 62-052, PL
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. wawrzyniaka 2; komorniki, 62-05 2, P; PL 62-052, PL
• Manufacturer Contact: kinga stolinska ; ul. ks. wawrzyniaka 2; komorniki, 62-05-2, P ; PL 62-052, PL
• MDR Report Key: 6885709
• MDR Text Key: 87227070
• Report Number: 3007420694-2017-00197
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/22/2017

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 Caregivers
• Device Model Number: BAB1000-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2017
• Distributor Facility Aware Date: 08/25/2017
• Device Age: 7 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/22/2017
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2017
• 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
• Patient Age: 88 YR
• Patient Weight: 44