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

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

Patient Problem Fall (1848)

Event Date 11/11/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Arjo was notified about incident of patient fall from the auto logic mattress and non arjo bed frame (avant guard 1400 hill rom).The patient was found on the floor.The customer indicated that bed was positioned in the lowest position and side rails were raised.

Manufacturer Narrative

On 14-dec-2018 arjo became aware of the incident involving auto logic mattress.Following the information provided the patient hospitalized for an cerebrovascular accident fell out of the medical devices.The incident occurred while he was trying to get out of bed (avant guard 1400 hill rom which is non-arjo device) on his own although his condition did not allow him to do so.He was found on the floor after the incident.As a result the patient did not sustain any injury nor apparent trauma.According to the facility staff at the time the patient's fall took place the bed was in its lowest position and the safety sides were raised.Additionally the patient had a 'bell' at his disposal so that he could communicate with the staff while needed.Arjo service technician was not able to inspect the mattress involved in the event due to the fact the facility staff did not reveal the serial number of the device in question.However it needs to be emphasized that there was no indication of mattress malfunction within the complaint description.The customer confirmed that the patient's fall occurred due to the fact the patient was trying to leave the bed despite his poor condition.Although there were no injuries reported, the complaint was decided to be reportable based on the indication of patient fall out of the bed that may lead to serious health consequences upon recurrence.There was no indication of mattress malfunction, therefore we assume that arjo device did not fail to meet manufacturer's specification and did not contribute to this unfortunate event.

• Brand Name: AUTO LOGIC
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road,; jiangsu, suzhou 21502 4; CH 215024
• MDR Report Key: 8230596
• MDR Text Key: 133935607
• Report Number: 3005619970-2019-00001
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2019
• Distributor Facility Aware Date: 12/14/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2019
• Date Manufacturer Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other