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

Model Number 630001

Device Problem Sharp Edges (4013)

Patient Problem Skin Infection (4544)

Event Date 03/24/2023

Event Type  Injury  

Event Description

The patient's wife reported that the metal part of the pump hanging bracket caused that the husband cut his toe.Hanging brackets (hooks) are located at the rear part of the pump and are used to secure the pump on the bed foot rail.The patient is being treated by a podiatrist the bed hook consists of metal rod covered by the pvc coating.According to information available at this time, the pvc coating come loose exposing the metal rod.

• 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, jiangsu 21502 4; CH 215024
• MDR Report Key: 16937188
• MDR Text Key: 315282340
• Report Number: 1419652-2023-00033
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 630001
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2023
• Distributor Facility Aware Date: 04/18/2023
• Event Location: Home
• Date Report to Manufacturer: 05/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male