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  Death  

Manufacturer Narrative

After reviewing the information provided it was determined that the family member alleged that there was a fault in the mattress that led to his/her mother having water in her lungs.There is no specific description of how water got into his/her mother's lungs or what the fault in the mattress was.There is also no details surrounding where or how the mattress was dipping and how this is related to water in his/her mother's lungs.The evaluation of the involved device was performed by arjo representative.No issue with the auto logic system was identified.Additional report ((b))(4)) will be submitted to document allegation that in the past a fault in the mattress also led to water in lungs.

Event Description

Arjo received a customer complaint with a suggestion from the complainant that his mother had passed away allegedly due to "the mattress fault had led to his mother having water in her lungs twice and said it was dipping at times.".

Event Description

Arjo received information from the complainant suggesting that "the mattress fault had led to his mother having water in her lungs twice and said it was dipping at times." allegedly his mother passed away due to mattress fault.

Manufacturer Narrative

Correction provided in sections: b1, b2, 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 and patient¿s death.Additonal report (importer report no 1419652-2020-00030) was submitted to document allegation that in the past a fault in the mattress also led to water in 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: 10156622
• MDR Text Key: 195216764
• Report Number: 1419652-2020-00028
• 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): Death; Other