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  malfunction  

Manufacturer Narrative

The evaluation of the involved device was performed by arjo representative.No issues with the mattress was identified.Evaluation of all collected information is ongoing.The conclusions will be provided to the follow-up report.

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 (b)(4)) to address an allegation that in the past a fault in the mattress allegedly led to water in user's lungs.

Manufacturer Narrative

Manufacturer narrative: please note that previous medwatch reports for this product may have been submitted under the following registration numbers: 1000381138, 3007420694.Currently, these products are to be handled by arjohuntleigh ab¿s complaint handling establishment and any medwatch reports will be submitted under registration 3005619970.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.There was no specific description how water got into lungs or what caused the mattress dipping.There were no details surrounding where or how the mattress was dipping and how this was related to water in lungs.A full function test was performed by arjo technician on the pump and mattress.This included powering on the pump, inflating the mattress, software testing, mattress cells were checked for leakage.When testing with load, the system adjusted for new pressures correctly.Tests showed that the system functioned as intended and no fault was detected.On (b)(6)2020, it was confirmed with (b)(6) (a healthcare provider to this patient) that they were unaware about any complaints or serious incidents being reported for this patient.In conclusion, 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: 10156738
• MDR Text Key: 195240734
• Report Number: 3005619970-2020-00011
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• 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
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: 05/29/2020
• 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