MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP Z O.O ATMOSAIR 9000A; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

Arjo was informed about 7 incidents of pressure ulcers.Pressure injuries have developed or progressed while being on atmosair 9000a surface in multiple locations, elbow, sacrum, coccyx, heels.No information about injuries outcome was provided by the customer nor serial number of the mattresses.Arjo clinical manager wound care reported that according to the customer (nurse) there was no correlation and that the nurse felt the pressure injuries were never related to the mattresses.This is fifth out of seven reports submitted.We report this event in abundance of caution due to limited information received and possibility of use error contributing to the pressure injuries.

Manufacturer Narrative

Arjo was informed about 7 incidents of pressure ulcers.Pressure injuries have developed or progressed while patients were on atmosair 9000a surface in multiple locations, elbow, sacrum, coccyx, heels.No information about injuries outcome was provided by the customer nor the serial numbers of the mattresses.This is fifth out of seven reports submitted.After the event, arjo clinical manager wound care contacted with the customer (ward nurse) to collect additional information related to event circumstances.The nurse was unable to provide information on when the patients were placed on the atmosair 9000a mattress.It was clarified by ward nurse that the facility has a turning protocol and admitted that the residents were repositioned (turned) every 2 hours or if not, the residents were able to reposition themselves.The device was not evaluated by arjo service technician.According to a conversation with the ward nurse, it was confirmed that the device was inspected by the customer and no obvious defect with the device was observed.Additionally, based onward nurse opinion, there was no correlation between the use of arjo mattresses and sustained injuries so the pressure injuries were never related to the mattresses.Moreover, after the event, the mattresses were not taken out of use as the customer did not determine that the device was a contributing factor to the reported event.There are different factors which might lead to developing a pressure ulcer.Patients nutrition, overall health, comorbidities, surface, turning schedule, microclimate will all contribute to the development of pressure injury.Despite efforts made to contact the customer, in order to gather detailed information about an incident, arjo has not received additional information that would allow us identifying the exact root cause of the reported issue.It has been established that the atmosair 9000a system was being used for patient therapy at the time of the event.Due to fact that the system was not identified and limited information was provided to complain the root cause of pressure ulcer cannot be defined with certainty.Initially, we have decided to report this case in an abundance of caution due to limited information received and possibility of use error contributing to the pressure injuries, however, after reviewing all the information gathered, it was concluded that there is no data reasonably suggests that arjo product caused or contributed to the reported issues.For this reason, any future similar cases will not be considered reportable to competent authorities.

• Brand Name: ATMOSAIR 9000A
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 8216556
• MDR Text Key: 133193827
• Report Number: 3007420694-2019-00007
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2019
• Date Report to Manufacturer: 01/29/2019
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other