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

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 (manufacturer report no 3005619970-2020-00011) 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.".

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.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.Because the alleged water in lungs due to mattress dipping occurred twice, two separate records were opened.The second report was submitted under mfr report number 3005619970-2020-00011.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 6-jul-2020, it was confirmed with the (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 and patient¿s death.

• 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: 10156623
• MDR Text Key: 195245429
• Report Number: 3005619970-2020-00010
• 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

• Date FDA Received: 06/16/2020
• 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
• Date Manufacturer Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other