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

Model Number S35

Device Problem Use of Device Problem (1670)

Patient Problems Laceration(s) (1946); Pneumothorax (2012)

Event Date 08/05/2018

Event Type  Injury  

Manufacturer Narrative

The alber representative reported that the patient's family was only aware of the aide being evaluated at two separate urgent care facilities, and on both occasions the doctors found no evidence of injuries and released her without treatment.The aide is now stating that she went to a hospital er and ended up in the icu due to a lacerated spleen and punctured lung.The patient¿s family requested medical records, but the aide has not provided any documentation to confirm the injuries.The alber representative advised that the patient has multiple sclerosis, and she has little body control, so when she is reclined in the scalamobil it is unlikely for her to be able to move forward.He does not believe that she moved in any way that would have contributed to the incident.The patient weighs approximately 200 pounds, which is under the maximum user weight of 308 pounds.The stairway on which the incident occurred has 6 steps total, but the patient and aide did not fall down all 6 steps.The weight shifted as they were partway down the stairs; the exact step where the event occurred is unknown.The alber representative advised that when he delivered the scalamobil on 06/11/2018, he inspected the stairs and operated the scalamobil on them, and no issues were identified.The steps met the necessary requirements.The alber representative also operated the device on the steps after the incident occurred, and it functioned properly without any issues.The underlying cause of the incident cannot be definitively determined; however, it was likely a result of use error.It is the responsibility of the aide to maintain the balance of the scalamobil during operation, and the aide did not receive proper training prior to using the device.The aide was not present for training at the time of delivery, and she did not receive training at a later date, even though the alber representative advised that training was required prior to operation of the scalamobil.The scalamobil user manual states, "the operation of the scalamobil without prior proper instruction is prohibited.Only persons instructed by an authorized dealer or an agent of alber are authorized to operate the scalamobil." a product malfunction has not been identified.In addition to the testing performed onsite at the patient's home, the scalamobil was brought back to alber usa for an evaluation, and it functioned properly.It will be sent to alber (b)(4) for further analysis.The patient also sustained a serious injury, which was reported in a separate medwatch report.

Event Description

An alber representative reported that the patient's aide was attempting to transport the patient down the steps using the scalamobil s35 when the weight shifted forward, and both the aide and patient tumbled down the steps.The aide fell over top of the scalamobil, and she allegedly sustained a lacerated spleen and punctured lung, and she was in the icu.

Event Description

An alber representative reported that the patient's aide was attempting to transport the patient down the steps using the scalamobil s35 when the weight shifted forward, and both the aide and patient tumbled down the steps.The aide fell over top of the scalamobil, and she allegedly sustained a lacerated spleen and punctured lung, and she was in the icu.

Manufacturer Narrative

On 10/11/2018, the scalamobil was inspected at alber germany by an independent testing agency, with an alber representative present.During the test, the device was fully operation, and no malfunctions were identified.Testing of the control switch did not indicate any faults; it functioned as specified.When continuous pressure was applied in the forward direction, the stair climber climbed down the staircase, and when continuous pressure was applied in the reverse direction, the stair climber climbed up the staircase.When the control switch was released, the scalamobil stopped immediately.The braking function of the individual safety brake wheels was also free from defects.On checking the adjustment, it was established that the safety brake wheels were aligned with one another.The wear of the brake linings of the safety brake wheels was measured, and all brake linings were within the specified tolerances.No faults which could cause falling were found during functional testing, with and without load.The inspector concluded that an operational error by the aide likely led to the fall alleged.

• Brand Name: S35 SCALAMOBLIE
• Type of Device: ELEVATOR, WHEELCHAIR, PORTABLE
• Manufacturer (Section D): ALBER GMBH; vor dem weissen stein 21; albstadt, baden-württemberg
• MDR Report Key: 7918242
• MDR Text Key: 122027362
• Report Number: 3004730072-2018-00008
• 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
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

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: Health Professional
• Device Model Number: S35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 09/28/2018
• Supplement Dates Manufacturer Received: 10/11/2018
• Supplement Dates FDA Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1