MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. ALPHA TRANCELL DELUXE PUMP; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number ALT04NL

Device Problem Deflation Problem (1149)

Patient Problem Ulcer (2274)

Event Date 01/15/2022

Event Type  Injury  

Manufacturer Narrative

The information was passed to the manufacturer.The investigation is in progress.Conclusions will be provided within the manufacturer's follow-up report once available.

Event Description

Following the information provided the mattress went soft.The issue was reported by the customer to arjo and resolved.Allegedly, due to malfunction the patient's pressure ulcers condition worsened from superficial wound(s) (stage 2) to a full thickness wound(s) (stage 4).

• Brand Name: ALPHA TRANCELL DELUXE PUMP
• 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: 13562022
• MDR Text Key: 285842338
• Report Number: 1419652-2022-00004
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALT04NL
• 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: 02/18/2022
• Distributor Facility Aware Date: 01/21/2022
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 64 KG