MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP Z O.O AUTO LOGIC; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number PXB001DAR

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Injury (2348)

Event Date 08/26/2019

Event Type  Injury  

Manufacturer Narrative

This report is being filed by (b)(4).Additional information will be provided upon conclusion of the manufacturer's investigation.

Event Description

It was reported to (b)(4) that a patient fell from a bed fixed with a auto logic system.Customer reported that the safety side of the bed was lowered.

Manufacturer Narrative

An investigation has been carried out onto this incident with the following conclusions.Arjo was informed about a patient fall from the arjo auto logic system.The customer stated that the safety side of the bed frame was not placed up when the incident occurred as these were not prescribed to this patient.Customer reported that incident involves a patient (68 years old) that was hospitalized for post-operative sepsis as part of an 11th-12th thoracic vertebra laminectomy.The patient was on anticoagulant, was disoriented and found hypoglycemic at 0.56 g/l after the fall.As a consequence of the fall, the patient sustained serious injury.Customer reported that recommendations specifying the constant need to raise the safety sides when using an air mattress were broadcast on the establishment; however, they were not followed.The customer facility reported no allegation of arjo product malfunction.The auto logic product user guide instruction for use (ifu) number 630933en_08 · 01/2019 warns about the responsibility the caregiver has in order to ensure that the user can use this product safely, additionally: "whilst the patient is unattended, the decision to use safety sides should be based on clinical assessment and in line with local policy".The auto logic system is designed to operate in either active (alternating) mode, which continuously changes the tissue pressure points providing a high degree of pressure relief, or reactive (constant lower pressure) (clp) mode, which provides a constant lower pressure reduction and is used when a moving surface is contra-indicated for the patient.The inflation/deflation is a slow process and does not produce a large impact to cause the patient fall.Approximate timings to inflate fully is 15 minutes; it is worth mentioning that patient should not be placed until it is fully inflated.In regards to time adjustment, the auto logic pump incorporates self set technology (sst), which adjusts air pressure within mattress every 10 minutes for the active (alternating) mode and 20 minutes for the reactive (constant lower pressure) (clp) mode to suit the body mass index (bmi) and position of the patient.Although the circumstances of this incident are unknown, it seems most likely that the customer staff did not follow their own recommendations; safety side barriers were not placed in the high position.The safety side barriers placement could have prevented the patient fall.When reviewing post market surveillance concerning patient fall, we have found 12 incidents (including one investigated here) reported by the same customer: bordeaux hospital.In conclusion, the arjo auto logic system (both mattress and pump) was used while the event occurred, therefore it played role in the event.There was no allegation of device malfunction.The patient's outcome from this fall was recognized as a serious injury.Arjo considers that the most likely cause of this incident is the fact that the customer staff not followed their recommendations on putting barriers in place while using auto logic air mattress.Arjo deemed this customer complaint as reportable to the competent authority as patient fall caused serious injury.

• Brand Name: AUTO LOGIC
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 9081255
• MDR Text Key: 163176026
• Report Number: 3005619970-2019-00016
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

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: Lay User/Patient
• Device Model Number: PXB001DAR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR