MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB ALPHA XCELL; FNM

Model Number ALX08

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

Patient Problem Pressure Sores (2326)

Event Date 07/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).On 17 jul 2015 arjohuntleigh was informed by the customer that "the system is still not fixed.Requires urgent attention.Pressure sores have developed as a result".No additional information regarding device, circumstances of the usage, potential failure or patient condition has been shared.Due to the limited information received relating to this complaint and with there being no information about the device output or symptom observed that originated the complaint, we are no able to determine what hazardous situation actually occurred.Nevertheless based on the allegation that the patient developed ulcer as a result of using our device, we decided to report the complaint to competent authority, even although the information about patient any injury and its severity was not confirmed.The customer was provided with a replacement unit, so that the one in question could be comprehensively tested.The visual and functional inspection performed by arjohuntleigh technician determined the system was in good condition and fully functional.The compressor was inspected, bellows were taken out and inspected for any wear however no deviations were found.The unit was tested - flow and pressure levels were within the specification.The allegation of device not working properly was not confirmed.The device was put back into service.As the provided problem description is limited, and a detailed witness description of what occurred is not available, we are left to review the information received from the customer, based on the device evaluation conducted by the technician and compare it to our product knowledge.By the unit testing performed we confirmed that our product at the time of the event was functioning as per its intended use however it is unknown whether and how it contributed to the reported event, despite our best efforts.The device was to specification and no malfunction appears to have taken place, the device was used for patient treatment and as such has reported to have contributed to a pressure sore, however we have not been able to occur if and how that would have happened.We report this event in the abundance of caution.

Event Description

On 17 jul 2015 arjohuntleigh was informed by the customer that "the system is still not fixed.Requires urgent attention.Pressure sores have developed as a result".Any additional information regarding device, circumstances of the usage, potential failure or patient condition has not been revealed.The customer was provided with the replacement unit, so that the one in question could have been comprehensively tested.

• Brand Name: ALPHA XCELL
• Type of Device: FNM
• Manufacturer (Section G): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house; houghton hall business park; houghton regis, bedfordshire LU5 5 XF; UK LU5 5XF
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5103681
• MDR Text Key: 26741777
• Report Number: 3007420694-2015-00184
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Remedial Action: Inspection
• Report Date: 09/25/2015,07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ALX08
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2015
• Distributor Facility Aware Date: 07/17/2015
• Event Location: Home
• Date Report to Manufacturer: 09/25/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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