MAUDE Adverse Event Report: ALBER GMBH SCALAMOBIL S30 IQ

Model Number S30 IQ

Device Problem Use of Device Problem (1670)

Patient Problems Abrasion (1689); Bruise/Contusion (1754)

Event Date 01/22/2020

Event Type  Injury  

Manufacturer Narrative

The incident occurred in (b)(6), alber is filing this report because the device was 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.A technical defect of the stairclimber can be excluded.The stairclimber was purchased privately by the patient's legal representative in an online shop for used medical products in (b)(6).We have no knowledge of whether the stairclimber was properly instructed and handled by the online shop or by the legal representative to the driving service or caregiver.Based on the information provided and the investigation, it was determined that the most probable cause of the event was an operating error.

Event Description

On (b)(6) 2020 reported by brother of the patient to alber (b)(4).Whilst the patient was transported down the stairs in his own home by the driving service/caregiver, the patient fell forwards (six steps) seated in the wheelchair with attached scalamobil.The patient was examined in hospital, abrasions and bruises were found, no stationary hospitalization.The alternating driving services /caregivers were instructed in the handling of the stair climber by the legal representative (brother of patient).The device was purchased privately by the legal representative in an online shop for used medical devices.

• Brand Name: SCALAMOBIL S30 IQ
• Type of Device: SCALAMOBIL S30 IQ
• 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: 9698710
• MDR Text Key: 178735791
• Report Number: 3004730072-2020-00003
• 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: 01/22/2020

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: S30 IQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2020
• Initial Date FDA Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2005
• 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