MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. FIRST STEP SELECT PUMP; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 215200

Device Problem Sparking (2595)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Following the information provided the customer placed a service call for pump not maintaining inflation.Upon written report the nurse received, it was indicated that the night staff noticed sparks at the side of the mattress and the pump stopped working.It was noticed that the power cord was damaged, internal wires were exposed showing scorched marks at the damage.The device was immediately taken out of use.Upon internal assessment it was determined that the cable was most likely ran over by the bed, which resulted in damage.No injury was sustained.

Event Description

Arjo received a customer complaint on first step select therapy system.Following the information provided, the customer¿s employee noticed sparks at the side of the mattress, then the pump stopped working and the mattress was deflating.The device was immediately taken out of use and the patient was transferred to another bed.It was remarked that the power cord was damaged, internal wires were exposed and there were scorched marks on the cord insulation.No injury was sustained.Upon internal assessment, it was determined that the cable was most likely ran over by the bed, which resulted in damage.This is in line with the power cord condition, confirmed by the photographic evidence provided.The insulation of the power cord was cut and scorched, and internal wires were visible.

Manufacturer Narrative

The information gathered in the course of the investigation indicate that the power cord was most likely ran over (trapped under casters) when the bed was being moved, which resulted in cable degradation and it could lead to alleged sparking.The instructions for use for first step select therapy system (document number: 416001) includes the following instructions related to the subject of the investigation: ¿ensure power cord is kept free from all pinch points and moving parts and is not trapped under casters.Improper handling of the power cord can cause damage to the cord, which may possibly produce risk of fire or electrical shock.¿.¿inspect all components for visible damage.Verify basic functionality and inspect all hoses, cords and other components for visible damage.Discontinue use and immediately contact manufacturer if damage is observed.¿.Based on the above, the integrity of the cord insulation must first be compromised, prior to damage the cable this way resulting in sparking.The device was used for a patient treatment when the event occurred.Arjo device failed to meet its performance specification since the power cord was damaged.The complaint was assessed as reportable due to allegation of spark emission from the damaged power cord and scorched marks on the cord insulation.Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (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).

• Brand Name: FIRST STEP SELECT PUMP
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• 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: 15494232
• MDR Text Key: 305993809
• Report Number: 3005619970-2022-00020
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 215200
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/27/2022
• Supplement Dates Manufacturer Received: 08/30/2022
• Supplement Dates FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Female