MAUDE Adverse Event Report: GETINGE (SUZHOU) CO., LTD. AUTO LOGIC; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 630001

Device Problems Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On april 15, 2019, arjo was notified about an incident involving auto logic system (pump and mattress).It was reported that a patient fell while trying to get out of the bed onto the commode; as per the patient's son, the mattress was flat and slippery.As a consequence of the fall, the patient was admitted to the acute medical unit finding a fractured pelvis; it is unknown which side was affected.Arjo collected the device and swapped out.

Manufacturer Narrative

An investigation has been carried out, and the conclusions are the following: it was reported to arjo that a resident (age 89, weight of 35 kg), fell from auto logic air mattress when trying to get out from bed onto the commode.Unfortunately, as an outcome of this fall, the resident fractured her pelvis.According to arjo mobility gallery (an assessment tool based on five different levels of mobility, named in alphabetic order from a to e), the involved patient was classified by arjo senior clinical advisor as "c"(incapable of performing daily activities without assistance, but is able to contribute to the action or perform part of the action independently).The incident was not witnessed and took place five days after the mattress was changed into the auto logic air mattress (mattress changed on may 10, 2019).The patient's son stated that the technician installed the mattress and left the site after informing that this process should take 20 minutes, and in case of any problems, there were phone numbers available at the pump.He stated that the mattress was partially inflated, but he did not report this to arjo, initialy, as assumed this was how the mattress should be.Upon the course of arjo investigation, there was found that the patient held onto the arms of the commode to pull herself up and she and commode toppled forward onto the floor.Son alleged that his mother had difficult to get off the bed since the mattress was soft and not fully inflated, which restricted her movements.Arjo senior clinical advisor informed that the room was not cluttered.This contained bed, commode, chair and sofa - no obstacles in fall area.After the incident, arjo technician reached the customer place.Mattress and pump were inspected.The mattress was found without malfunctions, therefore, it was left in situ and installed with a brand new pump.The pump, on the other hand, was found with visible external damages, that indicates it might have been dropped (as per arjo technician).Additionally, it was found set on constant low pressure mode.No correlation between soft mattress and a fall was found.The pump was collected and tested.The pump has went through all normal rental check such as pressures, flows and software test.As an extra test, the pump was connected to another arjo mattress for two hours.Although the pump case was damaged, no function deviations were found.Additionally, it was confirmed that before the pump was being rented to this customer facility, it was checked during the quality check (qc) inspection on may 01, 2019, passing all tests.The product user guide instruction for use (ifu) number 630933en_06 11/2017 warns: "it is responsibility on the caregiver to ensure that the user can use this product safely." in conclusion, auto logic system played a role in this unfortunate incident, since it was being used by the patient when the fall occurred.As an outcome of this event, the resident sustained a serious injury such a fracture of her pelvis.Patient's son allegations of mattress partially inflated was a result of setting the system on constant low pressure mode.We could not find a correlation between alleged soft mattress and a fall.It is most likely that the resident lost her balance when trying to stand up and consequently fell.Arjo has reported this incident to the competent authority due to the serious injury sustained by the patient after falling from the device.

Manufacturer Narrative

Arjo was informed on (b)(6) 2019, not on (b)(6), 2019, as was mentioned in the initial report.

Event Description

On (b)(6) 2019, arjo was notified about an incident involving auto logic system (pump and mattress).It was reported that a patient fell while trying to get out of the bed onto the commode; as per the patients son, the mattress was flat and slippery.As a consequence of the fall, the patient was admitted to the acute medical unit finding a fractured pelvis; it is unknown which side was affected.Arjo collected the device and swapped out.

• Brand Name: AUTO LOGIC
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, 21502 4; CH 215024
• MDR Report Key: 8639643
• MDR Text Key: 146059183
• Report Number: 3005619970-2019-00007
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 630001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2019
• Distributor Facility Aware Date: 05/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2019
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 05/15/2019; 05/15/2019
• Supplement Dates FDA Received: 05/28/2019; 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 89 YR
• Patient Weight: 35