MAUDE Adverse Event Report: ALBER GMBH SCALAMOBIL S39

Model Number EU:1521110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/06/2019

Event Type  Injury  

Manufacturer Narrative

The scalamobil was inspected.The scalamobil functions properly without any restrictions according to our specifications.A technical defect or malfunction of the device which caused to the event can be excluded.We make the educated guess that the event was caused by an operating error of the operator.

Event Description

Medical supply store informed alber (b)(4) that the husband of the customer tried to transport his wife down a 12-step stone staircase with the scalacombi s39.After reaching the fourth step and transition to the fifth, the small wheels on the device did not follow whilst the large wheels moved further.As a result the device lost its grip and the husband tried to pulling back the device to prevent a fall, but this did not succeed and both persons (wife on the device, husband as operator) fell down the remaining stairs and sustained serious injuries (patient broken fibula, operator broken lower arm) resulting in a four-day hospital stay.

• Brand Name: SCALAMOBIL S39
• Type of Device: SCALAMOBIL
• Manufacturer (Section D): ALBER GMBH; vor dem weissen stein 21; albstadt, baden-württemberg, germany
• Manufacturer (Section G): ALBER GMBH; vor dem weissen stein 21; albstadt, baden-württemberg,germany 72461 ; GM 72461
• Manufacturer Contact: christoph hauschel ; vor dem weissen stein 21; albstadt, baden-württemberg, germany 72461 ; GM 72461
• MDR Report Key: 9201014
• MDR Text Key: 162813147
• Report Number: 3004730072-2019-00007
• 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: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EU:1521110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2018
• 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