MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. THERAKAIR VISIO; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 413422-FRCA

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

Patient Problem Fall (1848)

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 from the therakair visio.The customer stated that days later the patient died.It was confirmed by the customer that the patient's death was not related with the fall.Based on the provided information no malfunction of the product was identified.There is no indication of any injury as a result of the fall.The patient was not hospitalized as a result of the event and did not need to go to emergency room.

Manufacturer Narrative

Based on the available information it is not possible to determine the root cause of the investigated scenario.There is no indication of any malfunction reported by the customer.No additional information were made available due to strict confidentiality of the information, as per the feedback provided by the customer.The customer requested from arjo to perform a reminding training session concerning use of therakair visio for all customer's staff.After the event an arjo representative performed a retraining session to the staff as per the customer¿s request.The instructions for use for therakair visio 340750-ah rev.F includes the following information addressing the potential risks of falling from the device: - "use or non-use of restraints, including side rails, can be critical to patient safety.Serious or fatal injury can result from the (.) non-use (potential patient falls) of side rails or other restraints." - "the therakair visio mrs is a mattress replacement system and should never be fitted before first removing the existing mattress from the bed.Fitting the therakair visio mattress on top of an existing mattress will raise the patient above the side rails of the bed, placing them at risk of falling out of the bed (.)." - "caregivers should assess risks and benefits of side rail/restraint use (including (.) patient falls from bed) in conjunction with individual patient needs, and should discuss use or non-use with patient and/or family.Consider not only the clinical and other needs of the patient but also the risks of fatal or serious injury from falling out of bed." - "when selecting a standard mattress, ensure the distance between top of side rails (if used) and top of mattress (without compression) is at least 8,66 in (220 mm) to help prevent inadvertent bed exit or falls.Consider individual patient size, position (relative to the top of the side rail) and patient condition in assessing fall risk." - "to minimize the risks of falls or injury the patient surface should always be in the lowest practical position when the patient is unattended." arjo device was used for a patient treatment when the event occurred and from that perspective it played a role in the event.There is no indication of any malfunction of the device.This complaint is deemed reportable due to the allegation of patient's fall from the device.H3 other text : device was not available for evaluation.

• Brand Name: THERAKAIR VISIO
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer (Section G): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 12778397
• MDR Text Key: 284639760
• Report Number: 3005619970-2021-00019
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

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
• Device Model Number: 413422-FRCA
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 10/14/2021
• Supplement Dates FDA Received: 12/08/2021
• 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 Sex: Female