S35 SCALAMOBLIE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-09-28 for S35 SCALAMOBLIE manufactured by Alber Gmbh.

Event Text Entries

[122028375] The patient was wearing a lap belt at the time of the incident, so she remained in the scalachair, which was connected to the scalamobil. 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 (b)(6) 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 (b)(4) 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 aide also sustained a serious injury, which was reported in a separate medwatch report.
Patient Sequence No: 1, Text Type: N, H10


[122028376] 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 patient sustained an injured foot and broken fibula.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004730072-2018-00009
MDR Report Key7918315
Report SourceCOMPANY REPRESENTATIVE
Date Received2018-09-28
Date of Report2018-09-05
Date of Event2018-08-05
Date Mfgr Received2018-10-11
Device Manufacturer Date2018-02-07
Date Added to Maude2018-09-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. JASON FIEST
Manufacturer StreetONE INVACARE WAY
Manufacturer CityELYRIA OH 44035
Manufacturer CountryUS
Manufacturer Postal44035
Manufacturer Phone8003336900
Manufacturer G1ALBER GMBH
Manufacturer StreetVOR DEM WEISSEN STEIN 21
Manufacturer CityALBSTADT, BADEN-W
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameS35 SCALAMOBLIE
Generic NameELEVATOR, WHEELCHAIR, PORTABLE
Product CodeING
Date Received2018-09-28
Returned To Mfg2018-10-09
Model NumberS35
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerALBER GMBH
Manufacturer AddressVOR DEM WEISSEN STEIN 21 ALBSTADT, BADEN-W?RTTEMBERG US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-09-28

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