MAUDE Adverse Event Report: ALBER GMBH SCALAMOBIL S35

Model Number S35

Device Problem Use of Device Problem (1670)

Patient Problem Concussion (2192)

Event Type  Injury  

Manufacturer Narrative

The incident occurred in (b)(6), alber is filing this report because the device is also marketed and sold in the u.S.A detailed investigation of the stairclimber was carried out.The stairclimber functions properly according to our specifications.Based on the information provided and the investigation, it was determined that the most probable cause of the event was an operating error by not observing the instruction for use.

Event Description

The operator (husband of the patient) informed the alber district manager that he was unable to maintain the balance of the stairclimber during a stair descent in his own home and that the stairclimber including wheelchair and patient fell 3-4 steps forward down the stairs.The patient (wife of the operator) suffered a mild brain concussion and had to be admitted to hospital.The patient has already been released from the hospital.The stairclimber was damaged by the fall and the left brake has broken off.

• Brand Name: SCALAMOBIL S35
• Type of Device: SCALAMOBIL S35
• Manufacturer (Section D): ALBER GMBH; vor dem weissen stein 21; albstadt 72461 ; GM 72461
• Manufacturer (Section G): ALBER GMBH; vor dem weissen stein 21; albstadt 72461 ; GM 72461
• Manufacturer Contact: christoph hauschel ; vor dem weissen stein 21; albstadt 72461 ; GM 72461
• MDR Report Key: 10032366
• MDR Text Key: 194487966
• Report Number: 3004730072-2020-00004
• 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: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: S35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2019
• 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): Hospitalization