MAUDE Adverse Event Report: MEDIBO MEDICAL PRODUCTS NV OTTER; FSA

Model Number DA0600

Device Problems Component Falling (1105); Unintended Movement (3026)

Patient Problems Fall (1848); Concussion (2192)

Event Date 01/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided following the conclusion of the investigation.

Event Description

Initially it was reported to arjohuntleigh representative that otter's seat lowered by itself during use: "a lady which being lifted from the pool, when the seat lost tension and dropped back towards the pool, causing the lady to hit their ankle and waist on the side of the pool".It was also reported "the attendant released the winding handle and this began to spin as the chair dropped back under the water with the user still seated".Device examination showed that pool lift was in good condition, during function test no fault was found.It was also not possible to re-create this event with applied force.

Manufacturer Narrative

An investigation was carried out into this complaint.When reviewing similar reportable events for otter we have found low number of other similar cases where otter's seat lowered by itself during use.We have been able to establish that there is no complaint trend concerning these kinds of events.The device was being used for the patient handling - removing patient from the pool, and in that way contributed to the event.It was reported by the customer that seat lowered uncommented - failed to operate in accordance to its specification.The device was inspected by an arjohuntleigh representative at the customer site, where several attempts have been made to re-create the event by placing weight on the chair, and the hoist behaved correctly under the tests.The gearbox has been replaced and returned to service center for further testing.Examined part did not show any anomalies.There was no record noting any defects or deficiencies.The gearbox was tested and strap replaced, in the same manner that any item would be serviced.Product instruction for use (ifu) is provided with each device.Ifu includes information about safe and correct use of the product.In ifu for otter pool lift there is a maintenance section which clearly informs that once a week caregiver should performed test by: fully raise and lower the seat using the winding handle for full and satisfactory movement.Also ifu contains the warning "if in any doubt about the correct functioning of the otter, withdraw it from use and contact arjohuntleigh service department." device examination performed by arjohuntleigh's representative showed that no failure was found that could contribute to this event.Also it wasn't possible to re-create this event.From all of above information we could not determine exact root cause of the alleged failure - since we could not find any failure.The device was in good working condition.

• Brand Name: OTTER
• Type of Device: FSA
• Manufacturer (Section D): MEDIBO MEDICAL PRODUCTS NV; heikant 5; hamont achel, BE 39 30; BE BE 3930
• Manufacturer (Section G): MEDIBO MEDICAL PRODUCTS NV; heikant 5; hamont achel, BE 39 30; BE BE 3930
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio,, TX 78247 ; 2103170412
• MDR Report Key: 5396221
• MDR Text Key: 37343821
• Report Number: 3007420694-2016-00011
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/28/2016,01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: DA0600
• 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: 04/28/2016
• Distributor Facility Aware Date: 01/04/2016
• Device Age: 7 YR
• Event Location: Other
• Date Report to Manufacturer: 01/28/2016
• Date Manufacturer Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2008
• 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 Weight: 80