MAUDE Adverse Event Report: GETINGE (SUZHOU) CO., LTD. ALPHAXCELL; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number ALX10

Device Problem Air Leak (1008)

Patient Problem Pressure Sores (2326)

Event Date 06/23/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 it was reported that the pressure sore at sacrum of a quadriplegic patient has deteriorated.Caregivers of the patient noticed a wound deterioration when refreshing a previously applied pressure ulcer dressing.Despite caregiver's reaction and application of the bandage, the ulcer did not improve.Patient's outcome is considered as serious.Arjohuntleigh was provided with a photographic evidence of the injury.It was suspected that the mattress has been not fully inflated (the cause yet unknown) and no low pressure alarm was launched.The device evaluation is ongoing.

Manufacturer Narrative

This report is being filed under exemption e2012066 by getinge (b)(4) co., ltd.(registration #3005619970) on behalf of the importer arjohuntleigh, inc.Ahus (registration #1419652).An investigation was carried out into this complaint.Arjohuntleigh was informed about an event which occurred during the therapy with alphaxcell system owned by the customer - caregivers of a quadriplegic patient noticed a deterioration of a pressure ulcer wound which was developed at the patient's sacrum a few days earlier.The pressure ulcer was assessed as stage iv (serious injury) presenting necrotic tissues with slough and bare sacral bone.The patient is currently cared for by a nurse specializing in home wound care, who treats the necrotic phase of the wound.In order to stop the evolution of the injury, nimbus system was delivered as a replacement for this patient.The information about a pressure ulcer development was not forwarded to arjohuntleigh until 25 jun 2017, when the notification about a worsening condition of the patient was received.Arjohuntleigh decided to document and report this incident within two separate reports - pressure ulcer development and pressure ulcer worsening.When reviewing reportable events on alphaxcell system, arjohuntleigh found one similar event which occurred in the past with the involvement of the same alphaxcell system used with the same patient who developed a pressure ulcer stage 3.The affected system was returned to arjohuntleigh and comprehensive device evaluation was performed.Upon the inspection it was revealed that pump internal components (pivots, bellows, silencer bag and gearbox) required a repair.The malfunction of the pump resulted in air leakage within the system.Following the observation of the service engineer, the pressure in the system was about 8-10 mmhg which was still above the trigger for the low pressure alarm.Mattress was found in a very bad condition which was supported by photographic evidence - mattress loops (securing cells in place) were found severely damaged, with weldings split.Cells were likely to move out of their correct position, creating an extra space in between, especially when loaded.Consequently, due to empty spaces created by shifted cells, the patient was likely to get in contact with a bed frame, especially in the event of pressure loss.Worth to mention is a medical condition of the patient who was paralyzed, not able to experience discomfort or pain from the neck down.The therapy was performed in a homecare environment.The patient who has already had a history of pressure ulcers may be considered to be at a high risk of pressure injuries.Although a compress was applied after the pressure ulcer was observed a few days earlier, it did not prevent from deterioration of the injury.No arjohuntleigh service was requested at the time and it is assumed that the patient was left on a malfunctioning mattress.Despite patient's impression that the device was not working correctly, the symptoms were not verified from a technical perspective and the system was continued to be used until the pressure sore has worsened.According to the instruction for use # (b)(4), troubleshooting section, the user is advised to call service engineer for maintenance if the system is suspected not to work as intended.During the interview it was established that the instruction for use was available for users.The system was not under arjohuntleigh service contract but was serviced by arjohutnleigh upon request.It seems that symptoms of a soft mattress and visibly damaged loop sheet were ignored and the system was continued to be used until the pressure sore deterioration.The malfunctioning system was in use for an unspecified period, but at least for a period of a few days (between pressure ulcer development notice and its worsening notice).This has exposed the patient already having a pressure ulcer developed to a health state deterioration.Following the conclusion of the investigation, it appears that the event of pressure ulcer deterioration was a result of an ineffective procedure of patient's monitoring and product maintenance (damaged mattress was left in use and no request for service until negative evolution of the injury).Nevertheless, the following factors were found as contributing: the condition of the involved mattress (damaged loops creating space between cells, allowing the patient to get in contact with a bed), air loss within the system which was still above the alarm triggering level and patient's medical condition (paralyzed patient in a homecare environment).We are reporting this incident to competent authorities due to a serious outcome of the event.It has been established that alphaxcell system which was in use for a patient therapy at the time of the event has malfunctioned and contributed to the reported outcome.

• Brand Name: ALPHAXCELL
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu, 21502 4; CH 215024
• Manufacturer (Section G): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; 21502 4; CH 215024
• Manufacturer Contact: kinga stolinska ; ul. ks. piotra wawrzyniaka 2; PL 62052
• MDR Report Key: 6711841
• MDR Text Key: 80010283
• Report Number: 3005619970-2017-00022
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: ALX10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2017
• Distributor Facility Aware Date: 06/25/2017
• Device Age: 8 YR
• Event Location: Home
• Date Report to Manufacturer: 08/10/2017
• Date Manufacturer Received: 06/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2009
• 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
• Patient Age: 52 YR
• Patient Weight: 60