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  

Manufacturer Narrative

Conclusions from the arjo investigation will be forwarded via a final report as soon as the investigation will be completed.

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.

Manufacturer Narrative

Despite attempts, the involved product could not be located and therefore could not be evaluated.We are in the process of compiling data.Once the conclusion is availabe the follow-up report will be submitted.

Manufacturer Narrative

Process of analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

Manufacturer Narrative

The information is still analysed.The follow-up report is to be submitted, when investigation conclusion is available.

Manufacturer Narrative

It was reported to arjo that a patient cut his toe on a damaged auto logic hanging brackets (bed hook).The patient was being treated by a podiatrist.The hanging bracket allows attaching the auto logic pump to the bed frame and consists of metal rod covered by the pvc coating.Allegedly, the pvc coating came loose exposing the metal rod.It is unknown in which circumstances the pvc coating on the pump hanging bracket could be damaged.Despite attempts to localize the pump and verify the customer's allegation, the pump could not be located.The quality check of the pump, which was performed after the device returned from rental, did not show any anomalies, the product passed the requirements.Additionally there was no service records related to the hooks replacement before the event and even after the event on 1 september, a repair that was performed on this pump had not hook included, but only the rear and front casing.This allowed us to conclude that the customer's allegation cannot be verified considering all the evidence provided.The auto logic service manual (b)(4) dated 11/2019 in section pump maintenance checks states to check the hooks for damage."if any parts are found to be damaged they must be replaced".We are unable to verify the customer's allegation related to metal part exposing, neither we can indicate the cause of the alleged pvc coating missing.A review of complaints related to the sharp edges from the hanging bracket used on autologic pump allowed to established that this complaint is a singular event.The arjo device was used for a patient¿s treatment when the event occurred and therefore played a role in the reported issue.No failure could be identified in the pump, that would explain the customer allegation.The complaint was decided to be reportable due to the serious outcome to the user.

• 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
• Manufacturer (Section G): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 16937189
• MDR Text Key: 315293254
• Report Number: 3005619970-2023-00008
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/06/2023

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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2023
• Date Device Manufactured: 10/30/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male