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

Model Number NPA0500

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 02/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On (b)(6) 2018 arjohuntleigh has become aware of an event involving maxislide flite, which occurred in advocate (b)(6) hospital located in (b)(6) usa.It was reported that one of the maxislide flites was left under the patient (male, (b)(6)) after his transfer on the cath lab table.The patient had to be pulled down towards the foot part of the table several times by staff, since he was anxious, agitated and was moving up the table.The resident was reported to be under hospital staff supervision.Following the information reported, the patient slid over the top of the lab table.It remains unclear if he reached the floor.A computed tomography (ct) scan of head was done after the incident and showed any negative results for head injury.No product malfunction was reported by the involved hospital staff, however, the sliding sheet was not evaluated by arjo representative as it had been discarded by the customer after the event.The review of similar reportable events involving the maxislide flites in last 5 years, revealed no other incident where it was indicated that the patient slid out of the bed or other surface, when placed on the sliding sheet.Maxislide flite is a disposable sliding sheet for single resident use intended for assisted handling routines of residents with limited ability to move.The maxislide flite sheets are used for lateral transfers and shall always be used in pairs of two.They consist of a rectangular sheet in a slippery material with reinforcing folds along the long edges.The maxislide flite sheets are intended for single resident use and shall not be cleaned, washed or disinfected.Before each transfer or repositioning, the patient should be properly assessed.The patient should never be left lying on the maxislide flites unattended and the slides should always be removed from under the patient after performed transfer or repositioning procedure.Following the information provided one of the slides was left underneath the patient.What is more, the patient was anxious, moving up to the head section of the lab table and had to be repositioned to the center of the table several of times.We found this as a contributing factor resulting in the patient's fall.The maxislide flites instructions for use (ifu, (b)(4) issue 5) warns: "an individual assessment of the patient's health condition should be carried out by a qualified nurse or therapist before each actual transfer / repositioning situation.Sliding techniques can be used successfully with patients of all dependency levels, but they should be subjected to a suitable assessment.Factors you should consider are environment, characteristics of the patient, the task you are performing and the caregiver's individual capability." "never leave the patient lying on the maxislide flites unattended." "remove maxislide flites from under the patient once the transfer/ repositioning is performed." following the above, if the ifu had been followed, the event would have been avoided.To conclude, the maxislide flite was used for patient's care and in this way contributed to the alleged event.As a consequence, the patient slipped out of the lab table when lying on the maxislide flite and from that perspective the product did not meet its performance specifications.We report this event to competent authorities due to potential for serious injury upon reoccurrence.

Event Description

On (b)(6) 2018 arjohuntleigh has become aware of an event involving maxislide flite, which occurred in advocate (b)(6) hospital located in (b)(6) usa.It was reported that one of the maxislide flites was left under the patient (male, (b)(6)) after his transfer on the cath lab table.The patient had to be pulled down towards the foot part of the table several times by staff, since he was anxious, agitated and was moving up the table.The resident was reported to be under hospital staff supervision.Following the information reported, the patient slid over the top of the lab table.It remains unclear if he reached the floor.A computed tomography (ct) scan of head was done after the incident and showed any negative results for head injury.No product malfunction was reported by the involved hospital staff, however, the sliding sheet was not evaluated by arjo representative as it had been discarded by the customer after the event.

• Brand Name: MAXISLIDE FLITES
• 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
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, ; PL
• MDR Report Key: 7372788
• MDR Text Key: 103946201
• Report Number: 3007420694-2018-00070
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: NPA0500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2018
• Distributor Facility Aware Date: 02/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2018
• Date Manufacturer Received: 02/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 141