MAUDE Adverse Event Report: MOTEK MEDICAL B.V. BODY WEIGHT SUPPORT LIGHT; POWERED EXERCISER

Model Number RB011

Device Problems Loose or Intermittent Connection (1371); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

Detailed and precise information about event and patient information from customer is still missing.We have attempted to get additional information from customer several times via email and phone, but until now, information was not provided.Further analysis according to inspection details are therefore ongoing.Root cause analysis is not completed.

Event Description

During a treatment session (gait rehabilitation), the yoke (attachment point of the patient harness) of the medical device (body weight support (bws) light) came loose and fell off.The patient did not get injured.Possible risk is that the yoke during treatment can detach and fall to the patient head from distance of about 15 cm, which can be very dangerous for specific patient population (patients after recent craniotomy/craniectomy surgery).It is important to note that patient harness is also attached to a safety line to prevent patients from falling, and this safety system was not affected and stayed operational throughout.

• Brand Name: BODY WEIGHT SUPPORT LIGHT
• Type of Device: POWERED EXERCISER
• Manufacturer (Section D): MOTEK MEDICAL B.V.; hogehilweg 18; unit c; amsterdam, noord-holland 1101C D; NL 1101CD
• Manufacturer (Section G): MOTEK MEDICAL B.V.; hogehilweg 18; unit c; amsterdam, noord-holland 1101C D; NL 1101CD
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 8540056
• MDR Text Key: 143033800
• Report Number: 3006750942-2019-00001
• Device Sequence Number: 1
• Product Code: BXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RB011
• Device Catalogue Number: RB011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention