MAUDE Adverse Event Report: ARJO DOMINICAN REPUBLIC AIRPAL; DEVICE, TRANSFER, PATIENT, MANUAL

Model Number 34N

Device Problems Inflation Problem (1310); Device Slipped (1584)

Patient Problems Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.The conclusions will be provided within the follow-up report once the investigation is completed.

Event Description

Following the information provided the patient fell to the side (not towards the bed) and then fell to the floor with mattress blown up still.The long strap on the side was stuck under the mattress, pulling against the patient going to the bed.No injury was sustained.

Manufacturer Narrative

Following the information provided in the user-facility medwatch report number (b)(4), the patient fell to the floor from inflated transferpad.No injury was sustained.The airpal transferpad is equipped with extended handles (pull straps) which are used to pull the mattress with the patient to complete the transfer.The pull strap on the side was stuck under the transferpad, creating an excessive friction and pulling the whole mattress against the direction of transfer.It affected the balance of the patient's weight distribution on the mattress during transfer, subsequently resulting in uneven inflation of the transferpad.The patient rolled to the side and fell as a result.The air distribution and inflation is dependent on the correct alignment of the patient on the center of the mattress.The user manual for airpal includes the following information related to the intended position of the patient on the device during transfer: - "to ensure the safest and most efficient transfer, the patient should be on the center of the transferpad.If the patient is off to one side, repositioning of the transfer pad will be necessary." it also informs the user that the outer side rail on receiving surface should be raised during transfer: - "side rail of the opposite side of the receiving surface, ie; bed/gurney, is raised and locked".Arjo device was used for a patient handling when the event occurred and from that perspective it played a role in the event.No malfunction of the device was reported.This complaint is deemed reportable due to allegation of patient fall from the device.

• Brand Name: AIRPAL
• Type of Device: DEVICE, TRANSFER, PATIENT, MANUAL
• Manufacturer (Section D): ARJO DOMINICAN REPUBLIC; building 9 piisa industrial pa km18 1/2 antigua carretera s; itabo 10903 ; DR 10903
• MDR Report Key: 12568400
• MDR Text Key: 274523031
• Report Number: 3012292104-2021-00024
• Device Sequence Number: 1
• Product Code: FMR
• 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: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 34N
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 97