MAUDE Adverse Event Report: ALBER GMBH SCALACOMBI S36; ELEVATOR

Model Number S36

Device Problem Use of Device Problem (1670)

Patient Problem Head Injury (1879)

Event Date 04/13/2017

Event Type  Injury  

Manufacturer Narrative

Device returned to manufacturer, no malfunction found.

Event Description

While the wife was using the scalacombi s36 to transport her husband down the stairs, the device allegedly tilted sideways to the wall causing her husband to hit his head.The husband was admitted to the hospital for head injury and lacerations.The event occurred in (b)(6).

• Brand Name: SCALACOMBI S36
• Type of Device: ELEVATOR
• Manufacturer (Section D): ALBER GMBH; vor dem weissen; stein 21,; albstadt, germany 72461 ; GM 72461
• Manufacturer (Section G): ALBER GMBH; GM
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 6572329
• MDR Text Key: 75344623
• Report Number: 3004730072-2017-00001
• 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: consumer
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/17/2017

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: Medical Equipment Company Technician/Representative
• Device Model Number: S36
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2017
• Initial Date FDA Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2014
• 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 Outcome(s): Hospitalization
• Patient Age: 57 YR