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  

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.

• 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: 10313023
• MDR Text Key: 200027943
• Report Number: 1419652-2020-00037
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982784283
• UDI-Public: (01)05055982784283(11)180123
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/23/2020
• Distributor Facility Aware Date: 07/09/2020
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR