MAUDE Adverse Event Report: ALBER GMBH S35 SCALAMOBLIE; ELEVATOR, WHEELCHAIR, PORTABLE

Model Number NA:S35

Device Problem Unintended System Motion (1430)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/22/2018

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.The product has not been returned, therefore an investigation has not been completed.When additional information becomes available, a supplemental record will be filed.

Event Description

This event happened in (b)(6).While using the s35 scalamoblie to take the end user downstairs it suddenly fell.The end user suffered some bruises, and he broke his nose in two places.He was admitted to the hospital for two days.

• Brand Name: S35 SCALAMOBLIE
• Type of Device: ELEVATOR, WHEELCHAIR, PORTABLE
• Manufacturer (Section D): ALBER GMBH; vor dem weissen; stein 21; albstadt 72461 ; GM 72461
• Manufacturer (Section G): ALBER GMBH; vor dem weissen; albstadt 72461 ; GM 72461
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 8077457
• MDR Text Key: 127353627
• Report Number: 3004730072-2018-00010
• Device Sequence Number: 1
• Product Code: ING
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/25/2018

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: Lay User/Patient
• Device Model Number: NA:S35
• Device Catalogue Number: S35
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2018
• Initial Date FDA Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2017
• 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): Required Intervention
• Patient Age: 74 YR