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

Model Number AXMRFPU35080TMS

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

Patient Problems Fall (1848); Head Injury (1879)

Event Date 02/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information will be provided when investigation conclusion will be available.

Event Description

Arjo was informed about a patient fall from a bed when laying on the atmosair 9000 mattress.As consequence of the fall, the patient sustained a head injury.Medical intervention was not needed, adhesive plaster was placed only.

Manufacturer Narrative

On (b)(6) 2020, it was found that the provided brand name: atmosair 9000 was not identified correctly.The claimed device was atmosair 9000a, therefore sections d1 and d2 corrected.

Manufacturer Narrative

Arjo was informed about a patient fall from a bed when laying on the atmosair 9000 mattress.As consequence of the fall, the patient sustained a head injury.Medical intervention was not needed, adhesive plaster was placed only.There was no allegation of the arjo device malfunction.According the information provided by the customer to arjo, the device alarm alerted the caregivers that the patient exited the bed.Following the event, the patient received a lower bed and fall mat so it can be assumed that the patient was classified as a high risk fall patient.From the above it can be stated that the patient¿s fall from the bed was most likely related to his medical state and not to atmosair 9000 mattress.To sum up, the arjo mattress was used during the reported fall and thus played role in the event, no product failure was found.Although there was no serious injury sustained, the complaint was decided to be reportable due to the allegation of the patient¿s fall.

• Brand Name: ATMOSAIR 9000A
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• MDR Report Key: 9833720
• MDR Text Key: 198766181
• Report Number: 3007420694-2020-00059
• 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,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AXMRFPU35080TMS
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 65