MAUDE Adverse Event Report: ALBER GMBH SCALAMOBIL; STAIRCLIMBER

Model Number S35

Device Problems Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problem Bruise/Contusion (1754)

Event Date 04/28/2015

Event Type  Injury  

Event Description

Information of the importer/customer: (b)(6) (importer fms) spoke with the mother who was operating the scala with her daughter ((b)(6)) being transported in the chair.The scalamobil s35 is mounted to a ki mobility cat 5 (16" wide) wheelchair).Amato (daughter - wheelchair user) and mom tumbled down the stairs.Both the mom and daughter received some bumps and bruises.According to the mom, she forgot to tighten the adjustment knobs on the handles and also forgot to remove the manual wheels from the wheelchair as advised in the user manual.The combination of the two resulted in the accident which caused the scala and chair to fall down the stairs.

• Brand Name: SCALAMOBIL
• Type of Device: STAIRCLIMBER
• Manufacturer (Section D): ALBER GMBH; GM
• Manufacturer Contact: christoph hauschel ; vor dem weissen stein 21; albstadt D-724-61 ; GM D-72461 ; 43220061
• MDR Report Key: 4802223
• MDR Text Key: 5931029
• Report Number: 3004730072-2015-00001
• Device Sequence Number: 1
• Product Code: ILK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/28/2015
• Device Age: 4 MO
• Event Location: Home
• Date Report to Manufacturer: 04/29/2015
• Date Manufacturer Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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 Age: 12 YR
• Patient Weight: 47