MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. ALPHA TRANCELL DELUXE PUMP; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number ALT04NL

Device Problem Deflation Problem (1149)

Patient Problem Ulcer (2274)

Event Date 01/15/2022

Event Type  Injury  

Event Description

Following the information provided the mattress went soft.The issue was reported by the customer to arjo and resolved.Allegedly, due to malfunction the patient's pressure ulcers condition worsened from superficial wound(s) (stage 2) to a full thickness wound(s) (stage 4).

Manufacturer Narrative

The investigation is in progress.The conclusions will be provided within the follow-up report once available.

Manufacturer Narrative

The device evaluation was performed.No malfunction was found.It was noticed that the pump was not turned on, the hoses were out and the mattress transport facility was set to transport mode.The transport mode can be activated manually by turning the transport valve knob by 90 degrees to the side.It is designed to keep the mattress inflated if there is a need to disconnect the pump for patient transport.After connecting the hoses back to the pump, disabling the transport mode and turning the pump on, it was confirmed that the pump was working as intended.It was established that the reason for softening of the mattress was the closed transport valve, which did not allow to change the pressure in the mattress.The arjo representative who delivered and installed the device states that he was sure that the transport valve was checked and it was open at the time of installation.The ifu for alpha trancell deluxe (500934en rev.6) includes the following information related to investigated scenario: - "before using the alpha trancell deluxe system make sure that it has been installed correctly in accordance to section 3, page 6 'installation'.(.) the transport control on the mattress is set to normal"; - "the transport facility is located on the tubeset near the pump.The patient may be transported on the alpha trancell deluxe systems as follows: - turn the knob 90 degrees (.), - remove the tubeset from the pump, - switch the pump to power: disconnect" - the pump evaluation revealed that the device was in exactly this condition as the ifu describes.Arjo device was used for a patient treatment when the event occurred and from that perspective it played a role in the event.The device was working as intended, but the customer was not aware of the transport function being active, hence from the customer's perspective the performance specification was not met.No malfunction was found during the device evaluation.This complaint is deemed reportable due to allegation of worsening the patient's condition - pressure injury aggravated from stage 2 to stage 4.

Event Description

On (b)(6) 2022 arjo was informed by the customer that on (b)(6) 2021 the arjo alpha trancell deluxe mattress went soft and as a result the patient's pressure ulcers condition worsened from superficial wound (stage 2) to a full thickness wound (stage 4).The complained mattress was used by the customer since (b)(6) 2022 and the pump involved in this incident was used since (b)(6) 2022.The customer called arjo representative and asked for assistance.The arjo rental technician contacted the customer and attempted to troubleshoot the issue on (b)(6) 2022.During the troubleshooting it was confirmed that: - the pump was constantly beeping, - reset of the pump by turning it off and back on did not allow to resolve the issue, - the valve in the hose was closed - increasing the pump pressure to the maximum did not change the mattress inflation level as per the caregiver.The arjo representative provided the replacement mattress for the customer.The injury sustained by the patient (worsening of the patient's stage 2 pressure injury to a full thickness stage 4 wound) was assessed by arjo clinical specialist as serious injury.

• Brand Name: ALPHA TRANCELL DELUXE PUMP
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer (Section G): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 13562015
• MDR Text Key: 286232723
• Report Number: 3005619970-2022-00001
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ALT04NL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 01/21/2022
• Supplement Dates FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2010
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 64 KG