MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. MAXI SKY 440; LIFT, PATIENT, NON-AC-POWERED

Model Number UNKNOWN

Device Problem Material Separation (1562)

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

Event Date 07/06/2022

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2022 arjo was informed about the scale adaptor failure (an accessory connecting the maxi sky 440 ceiling lift to the scale).Following the information provided, the strap of the scale adaptor connecting the ceiling lift with the scale detached during weighing a patient.As a result, the patient lowered on the bed placed below him.There was no injury sustained.The device involved in the incident was the ceiling lifting system, consisting of: arjo maxi sky 440 ceiling lift (with unknown serial and model number) attached to the ceiling installation, portable scale adaptor (with serial number: (b)(4) and model number: 700-05725), equipped with 4 straps mounted on rivets, suspended scale (with model number: 700-00531) with additional spreader bar.After the event, an arjo representative visited the customer to gather additional information and conduct the device inspection.The service technician observed that one of four straps of the scale adaptor came off from the rivet¿s head causing detachment of one side of the adaptor.There was no damage found neither on the adaptor strap, the maxi sky 440 ceiling lift nor the scale.Several possible reasons for the malfunction of the device were considered, but the exact circumstances under which the scale adaptor strap detachment occurred are unknown.Therefore, the root cause of the described problem cannot be determined.To sum up, the device was being used to weigh a patient when the malfunction occurred.Since the strap detached from the adapter frame, it can be concluded that the device failed to meet its performance specifications.The complaint was deemed reportable due to the indication that the scale adaptor detached during use with the patient.No injury occurred.

Event Description

On (b)(6) 2022 arjo was informed about the scale adaptor failure (an accessory connecting the maxi sky 440 ceiling lift to the scale).Following the information provided, the strap of the scale adaptor connecting the ceiling lift with the scale detached during weighing a patient.As a result, the patient lowered on the bed placed below him.There was no injury sustained.

• Brand Name: MAXI SKY 440
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5 Y5; CA J1X 5Y5
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5 Y5; CA J1X 5Y5
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 15111247
• MDR Text Key: 302182974
• Report Number: 9681684-2022-00053
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2017
• 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