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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/07/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation has been carried out onto this incident and conclusions are following.Arjo was informed about a patient fall from arjo auto logic mattress and an unknown bed frame.According to the customer, during the event bed's safety side rails were not in raised position.Specific patient medical condition was not provided apart that they are a paraplegic patient (b)(6).There was no injury reported as an outcome.Customer reported to arjo that they provided recommendations about raising the safety side barriers to their staff, however, they did not follow them at the time of the event.The customer facility reported no allegation of arjo product malfunction.The auto logic product user guide instruction for use (ifu) number 630933en_07 4/2018 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".Although the circumstances of this incident are unknown, it seems that its most likely cause is the fact 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 11 incidents (including one investigated here) reported by the same customer: (b)(6).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.Since the information provided is limited, it was not possible to determine the exact root cause of patient fall.We report this event due to allegation of patient fall, which may lead to serious health consequences.

Event Description

Arjo was informed about a patient fall from arjo auto logic mattress and unknown bed frame (brand name was not provided).The following information has been gathered from the customer: patient was not hurt as a consequence of this event.The barriers/safety sides were not raised when the event occurred.

• Brand Name: AUTO LOGIC
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, 21502 4; CH 215024
• Manufacturer (Section G): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, 21502 4; CH 215024
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 8783930
• MDR Text Key: 191915152
• Report Number: 3005619970-2019-00013
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 48 YR