MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. MAXXAIR ETS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 47129

Device Problem Disconnection (1171)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

The event information was passed to the manufacturer.The investigation is in progress.The conclusions will be provided within the manufacturer's follow-up report 3007420694-2023-00003 once the investigation is completed.

Event Description

Following the information provided the maxxair ets system was malfunctioning, contributing to difficulty with wound care.A tube inside the mattress would not stay connected causing air to leak out and the patient to lie lopsided (towards the affected side) on the bed.Lastly, because the device was malfunctioning and was not replaced, the nursing staff shut off the pump causing the patient to rest on a deflated mattress on top of a bed frame for approximately 2 days which they admit is the primary reason for the worsening condition of the wound.The patient had a hospital acquired pressure injury that did not occur as a result of the arjo device, however malfunctioning of the device likely contributed to worsening, or at least prevented improvement, of the wound.The injury that patient sustained was worsening of deep tissue injury that advanced to an unstageable (but likely stage iv) wound.The device was returned to arjo service for evaluation.

• Brand Name: MAXXAIR ETS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 16086359
• MDR Text Key: 306528760
• Report Number: 1419652-2023-00001
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 47129
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2023
• Distributor Facility Aware Date: 12/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 265 KG