MAUDE Adverse Event Report: ALBER GMBH SCALAMOBIL

Model Number S39

Device Problem Use of Device Problem (1670)

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

Event Date 07/09/2023

Event Type  Injury  

Manufacturer Narrative

This event occured in germany.Alber gmbh is filing this report because the device is also marketed and sold in the u.S.Alber performed an investigation of the returned device.The reported flashing of the red light could be reproduced.In the instruction for use the warning is described: "battery pack charge warning symbol [23] flashing red and ¿climbing down¿ symbol flashing green ¿ battery pack charge nearly 0 %; climbing stairs is not possible.Select ¿climbing down¿ mode, terminate the current operation and leave the stairs." the battery pack was disassembled to analyze the battery cells in more detail, it was found that "foreign" battery cells are installed.The installed battery cells are not battery cells offered by alber.The instructions for use explicitly refer to the replacement of the batteries: " we recommend using only batteries supplied by alber gmbh.The scalamobil is designed in such a way that best performance is achieved when using original batteries from alber gmbh." a maintenance was performed 28 apr 2023 but not by alber.No abnormalities were visible on the entire device which could lead to a malfunction of the stairclimber.There is no technical defect of the stairclimber.Due to the fact that "foreign" battery cells are/were installed, the stairclimber could not provide the necessary power during the transfer and generated an error message as intended.We assume that the event/fall was caused by an unintentional operating error.

Event Description

Narrative description of the initial reporter: whilst transferring the patient with the help of the stairclimber, the red battery warning light of the stairclimber was flashing and the stairclimber stopped the transfer on the staircase.The operator explained that the red battery warning light was flashing also a few days earlier before the event.The stop and therefore the interruption of the climbing process thus presumably led to the irritation of the operator, which resulted in the operating error and the fall of the patient.The patient suffered due to the fall a laceration on the head, a leg contusion and needed medical treatment in the emergency room.

• Brand Name: SCALAMOBIL
• Type of Device: SCALAMOBIL
• Manufacturer (Section D): ALBER GMBH; vor dem weissen stein 14; albstadt 72461 ; GM 72461
• Manufacturer (Section G): ALBER GMBH; vor dem weissen stein 14; albstadt 72461 ; GM 72461
• Manufacturer Contact: christoph hauschel ; vor dem weissen stein 14; albstadt 72461 ; GM 72461
• MDR Report Key: 17728829
• MDR Text Key: 323173616
• Report Number: 3004730072-2023-00009
• Device Sequence Number: 1
• Product Code: ING
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K920105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: S39
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization