FDA Adverse Event Injury Summary report: N

IBOT PMD

MDR report key: 17175129 · Received June 21, 2023

Report

Report Number: 3014522447-2023-00002
Event Type: Injury
Date Received: June 21, 2023
Date of Event: May 31, 2023
Report Date: June 21, 2023
Manufacturer: MOBIUS MOBILITY LLC.
Product Code: IMK
UDI-DI: 00857584008010
PMA / PMN Number: K210920
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NH, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THE ACTION OF THE USER AND SPOUSE WAS AN ATTEMPT TO ROTATE THE CLUSTERS IN ORDER TO SWITCH THE POSITION OF THE TWO SETS OF DRIVE WHEELS AND THUS TRY TO ENSURE EVEN TIRE WEAR. STAIR MODE IS ONLY INTENDED FOR USE ON STAIRS. PER THE USER MANUAL, "THE DEVICE DOES NOT BALANCE ITSELF DURING STAIR CLIMBING". THIS IS COVERED IN THE CERTIFICATE TRAINING PROGRAM FOR THE USER AND THE ASSISTANT DURING STAIR CLIMBING. IF STAIR MODE IS INITIATED ON LEVEL GROUND WITHOUT STEPS, AND THE DEVICE IS PULLED BACKWARD, THE DEVICE TIPPING AND FALLING OVER IS EXPECTED BEHAVIOR. THE INITIAL REPORT FROM THE USER STATED HIS SPOUSE ONLY SUSTAINED A BRUISED HIP. UPON FURTHER DISCUSSION WITH THE USER FIVE DAYS AFTER THE INITIAL REPORT, HE CLARIFIED THAT HIS SPOUSE BROKE HER PELVIS AS A RESULT OF THE EVENT. MOBIUS RETRIEVED THE LOGS FROM THE DEVICE. NO DEVICE MALFUNCTION WAS INDICATED IN THE LOGS. ASSESSMENT OF THE LOGS CORROBORATED THE USER'S ACCOUNT THAT A FALL HAD OCCURRED, AND INDICATED THAT THE FALL WAS DUE TO USER ERROR.

Description of Event or Problem · 0

USER INITIATED STAIR MODE ON LEVEL GROUND WITHOUT STEPS AND HAD HIS SPOUSE PULL BACK ON THE DEVICE. THIS RESULTED IN THE DEVICE FALLING OVER BACKWARD ONTO HER, BREAKING HER PELVIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2014733	IBOT PMD	IBOT	IMK	MOBIUS MOBILITY LLC.	IBOT PMD	N/A	00857584008010

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR	Female	Required Intervention