MAUDE Adverse Event Report: ALBER GMBH SCALAMOBIL S36

Model Number S36

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Abrasion (1689); Bruise/Contusion (1754); Laceration(s) (1946)

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

This event occured in (b)(6).Alber gmbh is filing this report because the device is marketed and sold in the u.S.Alber gmbh will start the physical evaluation of the device (device returned to alber gmbh 22 june 2021).

Event Description

The operator (nurse assistant/caregiver) wanted to transfer the patient down a staircase with 4 steps on (b)(6) 2021.After the second step, the stairclimber could no longer be operated, the seat and the backrest flew out and the operator and the patient fell down the stairs.The patient suffered lacerations, bruises, contusions and abrasions on the legs.The operator suffered bruises to the body and nose.Both the patient and the operator were treated at the emergency room of the hospital.The operator is employed as a nursing assistant/caregiver by the daughter.One of the patient's daughters instructed the operator in the handling and operation of the scalamobil.

Event Description

The operator (nurse assistant/caregiver) wanted to transfer the patient down a staircase with 4 steps on (b)(6) 2021.After the second step, the stairclimber could no longer be operated, the seat and the backrest flew out and the operator and the patient fell down the stairs.The patient suffered lacerations, bruises, contusions and abrasions on the legs.The operator suffered bruises to the body and nose.Both the patient and the operator were treated at the emergency room of the hospital.The operator is employed as a nursing assistant/caregiver by the daughter.One of the patient's daughters instructed the operator in the handling and operation of the scalamobil.

Manufacturer Narrative

The received stairclimber was examined in detail.From a technical point of view, no defects could be found which could have caused the accident described.According to the instructions for use (page 31), instruction on the device should have been given by a authorized dealer or agent of alber: "the scalamobil must only be operated by persons who have participated in the instruction session provided by the authorised dealer or an agent of alber gmbh.During the instruction session provided by your authorised dealer or an agent of alber gmbh, ensure that you are properly informed of all the functions of the scalamobil and its operation as a stair climber.In addition, test the device by climbing a staircase with an empty wheelchair to familiarise yourself with the stair climber¿s operating behaviour.¿ we make the educated guess that the incident described was caused by an operating error.

• Brand Name: SCALAMOBIL S36
• Type of Device: SCALAMOBIL
• Manufacturer (Section D): ALBER GMBH; vor dem weissen stein 14; albstadt, germany 72461 ; GM 72461
• MDR Report Key: 12056657
• MDR Text Key: 258016508
• Report Number: 3004730072-2021-00002
• Device Sequence Number: 1
• Product Code: ING
• Combination Product (y/n): N
• PMA/PMN Number: K920105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: S36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization