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 Date 11/15/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Following the information provided the power cord broke when customer lowered the bed onto it, causing the power cord to spark and the bed to shut down.The arjo representative attended the customer's site to evaluate the damage and confirmed damage of the power cord that resulted in scorched marks on the cord itself and the adherent air hose.Both faulty parts were replaced.There is no indication of patient involvement.No injury was sustained.

Manufacturer Narrative

The information gathered in the course of the investigation indicate that the power cord was trapped between moving parts of the bed (allegedly it was crushed when the bed was lowered by the customer).This is in line with the power cord condition, confirmed by the provided photographic evidence.The insulation of the power cord was crushed and melted, with scorched marks visible on the cord and pump hose.The damage to the power cord insulation resulted in cable degradation, which 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.Arjo device failed to meet its performance specification since the power cord was damaged.There was no allegation of patient involvement when the event occurred.This complaint is deemed reportable due to allegation of power cord damage resulting in emission of sparks.

Event Description

Following the information provided there was an allegation of first step select power cord damage resulting in the emission of sparks.There was no allegation of patient involvement.No injury was sustained.The customer¿s employee placed a service call.It was reported that when the customer lowered the bed, it resulted in a broken power cord.There were sparks showing and then the pump power went off.

• 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): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 15958651
• MDR Text Key: 307788459
• Report Number: 3005619970-2022-00031
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2022
• 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