MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. MAXISLIDE SHEET; AID, TRANSFER

Model Number NSA0500-US

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Injury (2348)

Event Date 03/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusions of the manufacturer's investigation.

Event Description

On (b)(6) 2018 arjo has become aware of an event that occurred at one of the facilities placed in colorado, usa.It was reported that a facility employee (manager) slipped on the floor, as he/she sat on a sliding sheet placed on a chair.As a result, the employee sustained an injury.No more information has been released.

Manufacturer Narrative

On (b)(6) 2018 arjo received information about an incident which occurred at one of the facilities in colorado, usa.It was initially reported to arjo representative that a facility employee (manager) has been sitting on the chair which was covered with the sliding sheet and suddenly slipped and fell on the floor.As a result of the event, the employee sustained an injury.Further information regarding severity of injury or course of the event was not disclosed at this time.On (b)(6) 2018 the arjo representative received an internal report with additional information from the customer facility.The circumstances of the event and type of injury were clarified.It was reported that when the employee (assistant nurse manager) placed other equipment in the utility room, she suddenly slipped on the sliding sheet.The employee did not notice that the sliding sheet was laying on the floor.Consequently, the employee lost her balance and in order to prevent from falling down, twisted her right side of the body.As a outcome, the nurse manager sustained lower back, pelvic muscle, and knee pain.Information provided by the facility indicated that there were available special line bags to storage the sliding sheets in the utility room at the time when the event occurred.All devices are delivered with instruction for use.The ifu for sliding sheet (nsx01000-int4) warns: "warning: ensure that sliding sheets are never dropped or left on the floor, as they are extremely slippy and accidents could occur." the event is a sequence of unfortunate events.The sliding sheet was left on the floor, the employee did not notice it, slipped, lost her balance and sustained injury.Review of reportable complaints showed that there are no related events.Therefore, the incident described above seems to be an isolated event to date.To conclude, arjo sliding sheet played a role in the complaint issue when the event occurred.As a consequence, the caregiver almost fall.No product defect was found.If caregivers follow guideline describing maxislide flites storage given in the instructions for use, the event would have been avoided.We reported this event to the competent authorities because of the initial allegation of an injury.In the course of the investigation, it was found that reported sequence of the events did not lead to serious injury.In light of this information, we do not consider this event as reportable compliant.

• Brand Name: MAXISLIDE SHEET
• Type of Device: AID, TRANSFER
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 7435505
• MDR Text Key: 106271573
• Report Number: 3007420694-2018-00090
• Device Sequence Number: 1
• Product Code: IKX
• 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
• Report Date: 05/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: NSA0500-US
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/28/2018
• Distributor Facility Aware Date: 03/19/2018
• Date Report to Manufacturer: 05/28/2018
• Date Manufacturer Received: 03/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR