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

Model Number BOB2001-01

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Date 08/22/2017

Event Type  malfunction  

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 being a manufacturer and 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).On 2018-jan-24 arjohuntleigh was notified about an incident which involved carino shower chair.It was reported that on (b)(6) 2017 during showering the patient the front right castor fell off.The patient slid down quickly onto the floor but did not sustain injuries.There were two staff members present when the patient was being showered.According to date of event it can be stated that arjohuntleigh was notified with a significant delay (over 4 months).On 2018-jan-26 the arjohuntleigh representative visited the customer facility to evaluate the involved device.During the visual inspection it was found that right front castor and right footstep fell off the device frame.The broken castor had a crack on its body, in area where it is attached to the frame.Beside these damages there were some scratches on the chair surface.Based on the arjohuntleigh report the device was not cleaned correctly.The customer facility did not have a contract for servicing the claimed device with arjohuntleigh.This unit was serviced by the customer facility, but the preventive maintenance schedule and service records were not made available for arjohuntleigh representative.According to the information provided by customer last chair maintenance was carried out on 2015-jun-16.The carino operating manual was available for the user.The review of similar reportable events with the involvement of the carino in last 5 years, did not reveal any other case where it was indicated that patient fell or slid off the chair due to castor detachment.Please note that according to the operating and product care manual (opci; 04.Bo.00/3gb issued in may 2004), which was delivered to the customer with the claimed device, a service routine has to be done on carino every year by arjohuntleigh authorized service personnel to ensure the safety and operating procedures of product (p.4).As per opci the equipment is subject to wear and tear, and the maintenance following the instructions available in preventive maintenance schedule must be performed when specified to ensure that the equipment remains within its original manufacturing specification.Safety-related maintenance must be carried out by qualified personnel, fully trained in servicing by arjohuntleigh, using correct tools and knowledge of procedures.Failure to meet these requirements could result in personal injuries and unsafe equipment (p.32).Based on the information provided by customer facility device was not serviced by arjohuntleigh, but by the facility personnel and previous maintenance was performed on 2015-jun-16.It means that over two years passed, since last service work till date the event occurred.Please note that following the opci preventive maintenance schedule customer should replace castors (wheels) every 2nd year.It was not confirmed when the device castors were replaced before the event, but according to the information regarding last maintenance, the damaged castor was in use for over 2 years.Moreover, to follow the opci guidelines the device user should check and clean castors every week: "check that the wheels are properly fixed and are rolling and swiveling freely." (p.30).If these actions are performed, this would decrease a risk of failure occurrence.The opci contains the recommended procedure of patient showering with use of carino shower chair (p.22) including the following points: "apply the brakes (.).Apply the leg rest.Wash and shower the resident in this position." to decrease the risk of patient fall from the device customer should (if needed) use safety strap, which will secure the resident in the chair.It should be underlined that it is highly improbable the patient would slide off the chair if the safety belt is applied.Please note that the patient assessment is not available, but according to the intended use presented in opci: "the resident needs to be able to sit in an upright position, normally defined as active or semi-active.All other uses must be avoided." (p.5).In addition, each carino shower chair is equipped with armrests, which could prevent from fall of the patient to the side.However, due to limited information it was not possible to determine the exact circumstances of event.Based on the collected information the involved device was failed to meet the manufacturer's specification as the malfunction occurred.At the time of event the device was used for treatment of the patient.This issue was reported due to information that involved patient slid off the chair which could have led to serious injury.

Event Description

On 2018-jan-24 arjohuntleigh was notified about an incident which involved carino shower chair.It was reported that on (b)(6) 2017 during showering the patient the front right castor fell off.The patient slid down quickly onto the floor but did not sustain injuries.There were two staff members present when the patient was being showered.According to date of event it can be stated that arjohuntleigh was notified with a significant delay (over 4 months).

• Brand Name: CARINO
• 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: 7281195
• MDR Text Key: 100669050
• Report Number: 3007420694-2018-00044
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2018

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
• Device Operator: Other Caregivers
• Device Model Number: BOB2001-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/19/2018
• Distributor Facility Aware Date: 01/24/2018
• Device Age: 12 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/19/2018
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2005
• 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