MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000; BATH, SITZ, POWERED

Device Problem Device Operational Issue (2914)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 07/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site (b)(4).As of 2014 that number was de-activated due to the site no longer shipping product to the usa.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted under (b)(4).Additional information will be provided upon conclusion of the manufacturer's investigation.

Event Description

Arjohuntleigh has received a customer complaint where it was reported that when the staff members were raising the lift with the resident in the sling the tub suddenly lowered lifting the support leg of the bath which afterwards landed on the caregiver's foot.As a result of the incident the patient sustained soft tissue damage to left foot.Caregiver is wearing a aircast.

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjo hospital equipment ab ltd (under registration #(b)(4)).As of 2014 that number was de-activated due to the site no longer shipping product to the usa.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4).On 31 july 2017 arjohuntleigh has been initially notified about an incident involving system 2000 bath.The event took place while transferring the patient ((b)(6) years old female, weighing (b)(6) ibs) from the bath at the end of tub using ergolift.According to staff when one of caregivers was lifting the resident from the tub the second one was lowering the bath.While doing this the emergency lowering actuator being part of the ergolift got caught on the end of the tub resulting in bath uplift for approximately 3-4 inches and its sudden drop.As a result one of bath's legs landed on caregiver's foot causing its soft tissue damage.The caregiver had to push the tub off her foot.After the event injured was taken to the emergency room and was hospitalized in (b)(6) hospital.Due to the injury sustained the caregiver in question was on modified duty wearing an aircast.According to the additional information provided we established the bath in question was under arjohuntleigh service contract.Moreover it was confirmed that the last staff training performed by arjohuntleigh was dated on june 2017, however there is no indication that caregivers being involved in the investigated issue participated in the training.After the event, the device was inspected by arjohuntleigh representative who found it in good condition, with all functions working correctly.As per customer the resident was said to be too large to fit in alenti lift hygiene chair therefore the ergolift was decided to be used to transfer the patient.According to information provided by the customer the resident's weight was (b)(6) lbs.Product instruction for use dedicated to alenti (operating and daily maintenance instructions (b)(4) dated on april 2000) informs "do not overload the lift hygiene chair! it has a lifting capacity of 160kg (352,74ibs)" what indicates patient's weight was suitable.Moreover it was reported that the resident was classified by customer facility clinicians as "carl" according to arjohuntleigh mobility gallery, which means that "this resident/patient is incapable of performing daily activities without assistance, but is able to contribute to the action or perform part of the action independently".The product ifu states that "the resident needs to be able to sit in an upright position, normally defined as active or semi-active.All other users must be avoided" what suggests that alenti is suitable for patients classification from "a" to "c".Taking into account ifu quote above the resident met criteria and alenti lifting chair was adequate to be used with the patient in question.Additionally it needs to be pointed out that at the time the incident occurred the legs of the lift were reported to be opened and the brakes were on.As per ergolift instruction for use ((b)(4) dated on september 2010) "brakes should not be used in the following situations: when raising a patient from a stationary position to allow the lift to auto-adjust to the patient's center of gravity.This will then keep the patient's from swaying".What is more, ifu of system 2000 ((b)(4) dated on september 1999) exactly specifies, what devices can be used to transfer a resident from/to the bath (p.34).On this list there was no ergolift device mentioned what suggests that ifu was not followed.To ensure the safety of our products current instruction for use provided together with the involved device indicates caregivers obligations while using system 2000 bath, which include: warning: "when lowering the bath tub the operator must ensure that there are no obstructions in the immediate vicinity that could impede its downward movement".In order to make sure that no incidents will happen in the future reminiscent staff training was scheduled.It was performed on (b)(6) 2017.The scope of the training was to remain the staff to access the tub from the side of the tub not from its end.The device was inspected after the event and no failure was found, it worked as intended.From the information collected to date, it seems that there are several factors that might together influence the event outcome: incompatible lift used with system 2000 bath and incorrect handling process.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.

• Brand Name: SYSTEM 2000
• Type of Device: BATH, SITZ, 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: 6770072
• MDR Text Key: 81904056
• Report Number: 3007420694-2017-00171
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 09/04/2017

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
• 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: 09/04/2017
• Distributor Facility Aware Date: 07/31/2017
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/04/2017
• Initial Date Manufacturer Received: 07/31/2017
• Initial Date FDA Received: 08/07/2017
• Supplement Dates Manufacturer Received: 07/31/2017
• Supplement Dates FDA Received: 09/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization
• Patient Age: 81 YR
• Patient Weight: 127