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

Model Number UNKNOWN

Device Problem Installation-Related Problem (2965)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 04/29/2023

Event Type  malfunction  

Manufacturer Narrative

The staff member did not notice the pump power cord when providing care and tripped over it.Product instruction for use (ifu) document number: 407390-ah, in safety information section states: ¿power cord ¿ position power cord to avoid a tripping hazard and / or damage to the cord.Ensure power cord is kept free from all pinch points and moving parts and is not trapped under casters.Improper handling of the power cord can cause damage to the cord, which may possibly produce risk of fire or electric shock¿.An arjo representative provided awareness to the customer representative on how to avoid tripping hazard.Arjo device was used for a patient treatment when the event occurred.The staff member tripped on the power cord.Arjo device did not fail to meet its performance as there was no malfunction on the device.The complaint was assessed as reportable as the claimed issue upon reoccurrence may result in serious injury.

Event Description

Arjo was informed about an event involving atmos air 9000a pump.Based on the collected information, the customer's employee tripped over the power cord and fell landing on the left wrist.The staff member's injury to the wrist that did not result in any swelling or treatment.

• 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
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 16983125
• MDR Text Key: 315743267
• Report Number: 3007420694-2023-00101
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: UNKNOWN
• Date Manufacturer Received: 05/04/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other