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

Model Number PXB001DAR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unclear Information (4052)

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

Event Date 08/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon the investigation conclusion.

Event Description

Arjo was notified by a customer that a patient fell out of the bed during the night.It was indicated that the safety sides were not in high position.

Manufacturer Narrative

Currently, we are still in the process of gathering additional information regarding the circumstances of the reported event.Further information will be provided upon conclusion of the investigation.

Manufacturer Narrative

Investigation has been carried out onto this incident and conclusions are following.Arjo was informed about a patient fall while on arjo auto logic mattress and non-arjo bed frame (brand name unknown).The customer stated that the event occurred when the patient was sleeping and that the safety sides were not raised.Specific patient medical condition was not provided.No allegation of product malfunction was reported by the customer.No failure was detected in the arjo service center when the system returned from rental, either.The product user guide instruction for use (ifu) number (b)(4) warns: "it is responsibility of the care giver to ensure that the user can use this product safely." "whilst the patient is unattended, the decision to use safety sides should be based on clinical assessment and in line with local policy".When reviewing reportable complaints for patient fall, we have found some incidents of patient fall, and 10 incidents have been reported by the one group of facilities from french market.After the events, arjo takes this matter very seriously and this is why arjo quality director for french market contacted the customer to help working on identifying the root cause of the issue.The customer facility representative stated that they are considering assessing patients on admit in order to select air mattresses for individual patient's needs.In summary, the auto logic system was used to treat the patient, for this reason, it played a role in this incident, however there was no allegation of device malfunction, the mattress did not fail to meet its specification.The circumstances of the event are unknown, it is unknown why the safety sides were not raised, what is the patient medical condition, what type of bed frame was used.Therefore is not possible to determine the exact root cause of patient fall.We report this event because of allegation of patient fall, which may lead to serious health consequences.

• Brand Name: AUTO LOGIC
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. wawrzyniaka 2; jiangsu; komorniki, 62-05 2, P; PL 62-052, PL
• MDR Report Key: 8159357
• MDR Text Key: 131311363
• Report Number: 3005619970-2018-00017
• 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: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2019

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: Lay User/Patient
• Device Model Number: PXB001DAR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2019
• Distributor Facility Aware Date: 11/19/2018
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2019
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 11/19/2018; 11/19/2018
• Supplement Dates FDA Received: 01/11/2019; 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other