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

Model Number 630001

Device Problems Deflation Problem (1149); No Apparent Adverse Event (3189)

Patient Problem Pain (1994)

Event Date 11/05/2022

Event Type  Injury  

Manufacturer Narrative

The complaint was reported as serious injury in abundance of caution as description of extreme pain in a situation where the mattress deflates and the patient is laying on a hard surface for several hours could indicate the formation of a deep tissue injury.

Event Description

It was reported by the patient's family member that an auto logic mattress deflated.The patient was laying on a hard surface for several hours and experienced "extreme pain".It is unknown if any medical intervention was needed.

Event Description

It was reported by the patient's family member that an auto logic mattress deflated and the audible alarm was triggered by the pump.The customer stated, that the patient was laying on a hard surface for several hours and experienced "extreme pain".Initially, the patient¿s sensation was assessed as a serious injury as ¿extreme pain¿ was thought to potentially indicate the formation of a deep tissue injury.And therefore, this complaint was deemed reportable to competent authorities.Later, arjo became aware that no serious injury occurred.The patient received the pain medication to deal with the pain and no medical intervention was needed.

Manufacturer Narrative

This report was submitted as additional information received allowed to clarify that no serious injury occurred.Report type (b1), describe event (b5), medical device problem code and health effect- impact code were corrected (f10).

• 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: 15860286
• MDR Text Key: 304283464
• Report Number: 1419652-2022-00047
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 630001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2022
• Distributor Facility Aware Date: 11/05/2022
• Device Age: 8 YR
• Event Location: Home
• Date Report to Manufacturer: 12/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female