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

Model Number ALT04NL

Device Problem Electrical Shorting (2926)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/16/2022

Event Type  malfunction  

Manufacturer Narrative

Based on the collected information the most likely root cause of the complained scenario is use error.The information gathered in the course of investigation indicate that the power cord was most likely caught within the bed moving mechanisms, probably when the backrest of the bed was raised.The damage to the cable resulted in short circuit, which subsequently blew a fuse in the hospital mains system, cutting off the power in two rooms.The instructions for use for alpha trancell deluxe (500934en) includes the following insctuctions related to the subject of the investigation: make sure that the mains power cable and tubeset or air hoses are positioned to avoid causing a trip or other hazard, and are clear of moving bed mechanisms or other possible entrapment areas.Where cable management flaps are provided along the sides of the mattress, these should be used to cover the mains power cable.Arjo device failed to meet its performance specification since the power cord was damaged.The device was used for a patient treatment when the failure occurred.This complaint is deemed reportable due to allegation of burning smell that was a result of smoldering of damaged power cord.Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (b)(4) and (b)(4).Currently, these products are to be handled by arjohuntleigh ab¿s complaint handling establishment and any medwatch reports will be submitted under registration (b)(4).

Event Description

Following the information provided by the caregiver burning smell could be felt by the bed when the backrest was raised.At the beginning of the care, the position of the head section of bed was set to horizontal.Then the caregiver left the room.After 5 minutes the caregiver came back and put the head section up.At this moment, the caregiver felt burning smell.The issue was immediately investigated, also because, the power was interrupted in another room.The customer¿s inspection revealed a damaged power cord of the alpha trancell deluxe pump.The pump was disconnected and swapped out for another one.At that time the patient was on the mattress.No injury was sustained.The evaluation of the pump performed by arjo representative revealed visible damage on the power cord with scorched marks.The arjo technician assessment indicated that the power cord could have been trapped between the moving parts and as a result it broke and shorted.This assessment is in line with the photographic evidence provided, which shows indentations in the cable.

• 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 15208756
• MDR Text Key: 305165016
• Report Number: 3005619970-2022-00014
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982788830
• UDI-Public: (01)05055982788830(11)190201
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ALT04NL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2019
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 54 KG