MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB AUTO LOGIC; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 630001

Device Problem Deflation Problem (1149)

Patient Problem Pleural Effusion (2010)

Event Type  Injury  

Manufacturer Narrative

The evaluation of the involved device was performed by arjo representative.No issues with the mattress was identified.

Event Description

This is second report created (the first report was submitted on 16th jun 2020 under mfr report number 3005619970-2020-00010, importer report number 1419652-2020-00028) to address an allegation that in the past a fault in the mattress allegedly led to water in user's lungs.

Manufacturer Narrative

Corrected data in sections: b1 and d3.Arjo auto logic system was being used for home care treatment.Arjo decided to report this complaint due to allegation that "the mattress fault had led to his mother having water in her lungs twice and said it was dipping at times."the customer allegation was not confirmed during the system evaluation, as no fault or malfunction was found, the mattress functioned as intended.Based on currently available information, there is no indication that the mattress caused or contributed to the alleged water in patient¿s lungs.

Event Description

This is second report created (the first report was submitted on 16th jun 2020 under mfr report number 3005619970-2020-00010, importer report number 1419652-2020-00028) to address an allegation that in the past a fault in the mattress led to water in user's lungs.

• Brand Name: AUTO LOGIC
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house, houghton hall business park; houghton regis, bedfordshire LU5 5 XF; UK LU5 5XF
• MDR Report Key: 10156741
• MDR Text Key: 195240512
• Report Number: 1419652-2020-00030
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

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?: Yes
• Device Operator: No Information
• Device Model Number: 630001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2020
• Distributor Facility Aware Date: 05/29/2020
• Event Location: Home
• Date Report to Manufacturer: 07/14/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other