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

Model Number AP03312-US

Device Problem Device Tipped Over (2589)

Patient Problem No Patient Involvement (2645)

Event Date 12/21/2016

Event Type  malfunction  

Manufacturer Narrative

(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 the tub has tipped over while it was being filled.There was nobody in the room at the time of the incident.Arjohuntleigh technician has visited the facility after incident and found that the left rear bolt on the leg support was broken.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events for system 2000, we have found a low number of similar cases where the tub has tipped over due to leg bolts breakage.There is very low occurrence rate for this kind of events.The incident occurred when the tub was being filled with the water.It was stated that the leg bolt has snapped what lead to the bath's fall.Root cause analysis was performed using ishikawa diagram.It is worth noting that this bath has been under arjo service contract and was checked four times during the year before incident.Before releasing for use by the technician, the bath needs to be in full working condition.What is more, maintenance and repair manual ((b)(4)) gives clear instructions: "screws holding legs shall be checked for torque every year." "torque 44 nm.Check every year." therefore, the exact root cause which would be poor maintenance, inaccurate instruction or technician's error can be excluded.The age of the device is significant for this malfunction.Looking at the date of the production of this device, it was manufactured in 2002 and has already passed its operational lifetime as identified in the device labelling 4 years before incident.As stated in the operating and daily maintenance instructions ((b)(4) 2001): "the normal useful life of this equipment, unless otherwise stated, is ten (10) years, subject to required preventative maintenance as specified in the operating and daily maintenance instruction, the assembly and installation instructions and the spare part catalogue." engineering department was consulted in order to understand if the failure could have been visible during the maintenance performed 4 months before the incident.The opinion was that the wear and damage of the bolt is rarely visible when this bolt is exposed to the shear forces.Therefore the technician could have not been able to notice and predict the fracture.As a result, the age of the device is most likely root cause for this complaint.The device was outside of its intended lifetime at the time of the event and the customer will be suggested to take it out of use.This complaint is reported in abundance of caution.The device was not being used for patient care at the time of the incident, it was not to specification most likely due to not following the lifetime indications in the labelling.The device did not play a role in an actual adverse event.

• 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 ; 98282467
• MDR Report Key: 6259945
• MDR Text Key: 65085679
• Report Number: 3007420694-2017-00013
• 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: Repair
• Type of Report: Initial,Followup
• Report Date: 02/17/2017

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: No Information
• Device Model Number: AP03312-US
• 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: 02/17/2017
• Distributor Facility Aware Date: 12/21/2016
• Device Age: 14 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/17/2017
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 01/18/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2002
• 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