MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. FLUIDAIR ELITE; BED, AIR FLUIDIZED

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site kinetic concept inc (under registration #(b)(4)).From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under registration #(b)(4).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).Additional information will be provided upon conclusion of the investigation.

Event Description

It was reported to arjo that two of the staff members sustained injuries while repositioning patients on fluidair (s).There were two separate incidents involving two staff members and two beds at the same facility, on the same weekend.First event has been registered under medwatch 3007420694-2018-00021.Since information regarding the subject (injury sustained as well as description of the event) is inaccessible at this time, we report this incident in abundance of caution because of the allegation of an injury.

Manufacturer Narrative

Please note, that since 10th january 2018 we have made several attempts to contact the customer and gather additional information regarding the incident reported.On 27th february 2018 we have been informed by the customer that incident occurred in (b)(6) 2017 and that the injury was "beyond first aid and involved back/shoulders injuries".The investigation is still ongoing, additional information will be provided upon conclusion of the investigation.

Manufacturer Narrative

The investigation has been completed and conclusions are following.On 5 january 2018 an arjohuntleigh was notified about 2 incidents with the involvement of fluidair elitetm therapy system indicating that customer staff were injured while patient repositioning.In order to obtain more information to the reported incidents, we have contacted the customer several times.After the attempts, on 27 february the customer informed that total of 4 staff injuries sustained.Therefore additional 2 incidents have been recorded (all have been reported separately to competent authority under mdr 3007420694-2018-00021, 3007420694-2018-00072 and 3007420694-2018-00073).The injuries occurred on 7, 17, 24 and 31 december 2017 as a result of repetitive motions while repositioning patients on the bed wedges over a period of time.The customer reported that "all injuries were beyond first aid and involved back/shoulders injuries", however refused to provide detailed information on the types of injuries.Additionally, only one serial number of the bed was identified by the customer as involved in at least two incidents ( reported under mdr 3007420694-2018-00021 and 3007420694-2018-00022).There was no allegation indicating technical failure within the bed.The customer stated that the bed design does not allow for proper body mechanics when repositioning onto the wedge.Also that there is no safe patient handling equipment approved by manufacturer for repositioning of post flap spinal cord injury patients.Please note that foam wedges are installed under patient's head, if required, to raise the patient torso.User manual (b)(4) rev.C dated on february 2015 provides the following indications, warnings and precautions: 1."general protocol - follow all applicable safety rules and institution protocols concerning patient and caregiver safety".Every hospital has their own protocols that dictate how patients are turned for both the safety of a caregiver and patient.Information received from arjo account manager was that the injury occurred potentially due to a positioning technique used during training.2."patient repositioning using dri-flo underpad.1.Lower side rails.2.Take position on each side of patient (two people will be needed).Roll edges of dri-flo on each side of patient to get a firm grip.To lift and properly position patient in the unit.3.Note: the retractable side step on each side of the unit may be lowered to facilitate repositioning.4.Use dri-flo underpad to lift and properly position patient in unit." taking the above into account, the customer allegation cannot be acknowledged.There was no allegation of product failure that could contribute to the injury but rather user repositioning techniques contributed to the issue.Because four incidents occurred at one facility and it seems that repositioning techniques or incorrect protocol used contributed to the reported issue, a re-training will be scheduled at the customer convenience.Initially, this complaint was assessed as reportable due to information of staff injury.After multiple unsuccessful attempts to gain additional information from the customer on the types of injuries alleged, no information that would suggest any serious injuries was provided by the customer.There was no allegation of product failure, but user techniques used while patient repositioning contributed to the issue.Since the four incidents were reported by one customer, they are considered singular occurrence.No other similar complaints have been found.For this reason, we do not consider this event reportable to competent authorities in the future.The device did not fail to meet its performance specification, it was used for a patients treatment at the time of incidents and therefore played role in the events but was not directly involved with the reported injury.

• Brand Name: FLUIDAIR ELITE
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 7227036
• MDR Text Key: 98978877
• Report Number: 3007420694-2018-00022
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2018

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/05/2018
• Initial Date FDA Received: 01/30/2018
• Supplement Dates Manufacturer Received: 02/27/2018; 02/27/2018
• Supplement Dates FDA Received: 03/01/2018; 03/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other