FDA Adverse Event Injury Summary report: N

IBOT PMD

MDR report key: 20780432 · Received November 26, 2024

Report

Report Number: 3014522447-2024-00002
Event Type: Injury
Date Received: November 26, 2024
Date of Event: November 5, 2024
Report Date: November 25, 2024
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

MOBIUS MOBILITY INTERVIEWED THE USER AND RETRIEVED THE EVENT/ALARM DATA AND BLACK-BOX DATA FROM THE DEVICE. THESE DATA CONFIRM THE DEVICE ENTERED 4-WHEEL MODE FROM STANDARD MODE ON (B)(6) 2024 AT 10:30:38. AFTER DRIVING FORWARD ON ROUGH TERRAIN (SLIGHT OSCILLATION OF DEVICE AND CLUSTER ANGLES) FOR APPROX. 10 SECONDS, THE DEVICE DESCENDED A STEP OR CURB. THE DEVICE THEN PITCHED FORWARD, LOST WHEEL TRACTION, AND ROLLED TO THE SIDE. THE DEVICE RECORDED A SEAT BRAKE SLIP AND POWERBASE ALERT INDICATING A CONTROLLER FAILURE CONDITION DUE TO EXCEEDING ITS ROLL LIMIT. THE DEVICE WAS SUBSEQUENTLY POWER CYCLED AND RECOVERED WITH NO OTHER RELEVANT INFORMATION PRESENT IN THE DATA LOGS. THERE IS NO INDICATION OF DEVICE MALFUNCTION. THE LIKELY CAUSE IS THAT THE USER DID NOT PROPERLY ALIGN WITH THE CURB COMPOUNDED BY TOO MUCH SPEED. USER MANUAL PAGE 94: "APPROACH OBSTACLES STRAIGHT ON AT SLOW, STEADY SPEED."

Description of Event or Problem · 0

USER CALLED INDICATING HE HAD ROLL OVER INCIDENT. HE SAID HE WAS GOING OFF A CURB AND WAS DISTRACTED BY A CAR TURNING THE CORNER AND MAY HAVE TAKEN THE CURB TOO QUICKLY, WITHOUT PROPER ATTENTION, RESULTING IN THE TIP OVER. THE TIP OVER RESULTED IN 7 STITCHES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2569529	IBOT PMD	IBOT	IMK	MOBIUS MOBILITY LLC.	IBOT PMD	N/A	00857584008010

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR	Male	Required Intervention