MAUDE Adverse Event Report: ALBER GMBH SCALAMOBIL S35

Model Number S35

Device Problem Use of Device Problem (1670)

Patient Problem Head Injury (1879)

Event Date 07/12/2020

Event Type  Injury  

Manufacturer Narrative

The incident occurred in (b)(6), alber is filing this report because the device is also marketed and sold in the u.S.A criminal complaint against the operator (nursing service) was raised.The case is being investigated by the police and public prosecutor's office.The stairclimber is secured as evidence and as of today not available for a manufacturer's examination.Based on the information provided the most probable cause of the event is an user error.Device secured as evidence by police.

Event Description

Medical supply store informed alber (b)(4) that the operator (nursing service) wanted to transport the patient downstairs (scalamobil with attached wheelchair), but the patient slipped forward out of the wheelchair and fell down the stairs.The patient suffered head injuries and was admitted to the intensive care unit at the hospital.The wife of the patient has filed a criminal complaint against the operator (nursing service).The medical supply store informed that an user error is most likely.

Manufacturer Narrative

Alber has requested within the time frame from jul 2020 till jan 2021 several times to make the involved stairclimber available for an investigation, however, at the time of this report, the involved stairclimber has not yet been released by the police/prosecutor's office.Due to the fact that the stairclimber has not yet been made available for an investigation after being requested three times, this report will be submitted and this case will be closed by alber.If we get subsequently information that this event was not caused by an user error and/or should the stairclimber be made available for an investigation this case will be reopened and follow up report will be submitted.H3 other text : not yet available for investigation.

Event Description

Medical supply store informed alber gmbh that the operator (nursing service) wanted to transport the patient downstairs (scalamobil with attached wheelchair), but the patient slipped forward out of the wheelchair and fell down the stairs.The patient suffered head injuries and was admitted to the intensive care unit at the hospital.The wife of the patient has filed a criminal complaint against the operator (nursing service).The medical supply store informed that an user error is most likely.

• Brand Name: SCALAMOBIL S35
• Type of Device: SCALAMOBIL S35
• Manufacturer (Section D): ALBER GMBH; vor dem weissen stein 14; albstadt 72461 ; GM 72461
• MDR Report Key: 10312655
• MDR Text Key: 202008109
• Report Number: 3004730072-2020-00005
• Device Sequence Number: 1
• Product Code: ING
• Combination Product (y/n): N
• PMA/PMN Number: K920105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

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: S35
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization