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

Model Number 630EUR

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing, the additional information will be provided to the follow-up report.

Event Description

Arjo received information that a critical patient with comorbidities and burns (burned over 60% of their body) developed pressure ulcers lying on deflated auto logic mattress.A low pressure alarm was triggered by the arjo pump which correctly detected the low pressure within the mattress.

Manufacturer Narrative

Arjo received information from the customer that a critical patient with comorbidities and burns (burned over 60% of their body) developed a serious injury (pressure ulcers) allegedly because auto logic mattress deflated.In the reported complaint, it was stated by the customer that a low pressure alarm was triggered by the arjo pump which correctly detected the low pressure within the mattress.Following the event, the involved system was returned to the arjo service centre.The system evaluation performed by an arjo technician did not confirm the alleged issue.No malfunction in the mattress or pump was found.This would be in line with the condition of the mattress reported by the customer, who stated they left the patient on this mattress for two another days since the mattress functioned properly.Based on the performed investigation, it was concluded that the involved patient was at the highest risk of pressure sore development (patient with comorbidities and burns).Device instructions for use (ifu 630933en) includes following information: ¿the auto logic systems are indicated for the prevention and/or management of all categories of pressure ulcer, when combined with an individualised, comprehensive pressure ulcer protocol: for example, repositioning, nutritional support, skin care.Selection should be based upon a holistic assessment of the patient¿s individual care needs.¿ in conclusion, arjo auto logic system (used for treatment of the patient) deflated, therefore the system did not meet the performance specification at time of event.Arjo has decided to report this complaint due to reported outcome, the patient developed the serious injury.

Manufacturer Narrative

Following the event, the involved system was returned to the arjo service centre.The system evaluation performed by an arjo technician did not confirm the alleged issue.No malfunction in the mattress or pump was found.Conclusions from the investigation will be provided to the next report.

• 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: 10312521
• MDR Text Key: 200006129
• Report Number: 3005619970-2020-00015
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982784283
• UDI-Public: (01)05055982784283(11)180123
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 630EUR
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR