MAUDE Adverse Event Report: ALBER GMBH SCALAMOBIL S30 IQ; ELEVATOR

Model Number EU:SCALAMOBILS30IQ

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

This event occurred in (b)(6), invacare is filing this report because the device is also marketed and sold in the u.S.An investigation of the event and inspection of the device are being performed by (b)(6).An initial test of the device showed no malfunction.Further investigation is in process.When additional information becomes available, a supplemental record will be filed.The owners manual has many warnings including: in principle every climbing process has to be completed.However, if the situation arises and you must interrupt the climbing process, lay the scalamobil with the attached wheelchair backwards on the stairs.Due to the safety brakes, it is impossible that the scalamobil rolls over the edge of the step.

Event Description

This event happened in (b)(6).Limited information was provided, (b)(6) is attempting to get further details.While using the scalamobil to take the patient downstairs, the device became blocked in the middle of the stairs causing an event that resulted in a nasal bone fracture.

Manufacturer Narrative

Alber germany completed their examination of the device.They found that the device functions properly without any restrictions or malfunctions according to its specifications.

Event Description

This event happened in germany.Limited information was provided, europe is attempting to get further details.While using the scalamobil to take the patient downstairs, the device became blocked in the middle of the stairs causing an event that resulted in a nasal bone fracture.

• Brand Name: SCALAMOBIL S30 IQ
• Type of Device: ELEVATOR
• Manufacturer (Section D): ALBER GMBH; vor dem weissen; stein 21; albstadt
• MDR Report Key: 7806191
• MDR Text Key: 117901010
• Report Number: 3004730072-2018-00006
• Device Sequence Number: 1
• Product Code: ING
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/25/2018

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: No Information
• Device Model Number: EU:SCALAMOBILS30IQ
• Device Catalogue Number: SCALAMOBILS30IQ
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 08/22/2018
• Supplement Dates Manufacturer Received: 08/29/2018
• Supplement Dates FDA Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention