MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-23 for BODY WEIGHT SUPPORT LIGHT RB011 manufactured by Motek Medical B.v..
[143033800]
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.
Patient Sequence No: 1, Text Type: N, H10
[143033801]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006750942-2019-00001 |
| MDR Report Key | 8540056 |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-23 |
| Date of Event | 2019-03-27 |
| Date Mfgr Received | 2019-03-27 |
| Date Added to Maude | 2019-04-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KEVIN WALLS |
| Manufacturer Street | 33 GOLDEN EAGLE LANE |
| Manufacturer City | LITTLETON CO 80127 |
| Manufacturer Country | US |
| Manufacturer Postal | 80127 |
| Manufacturer Phone | 7209625412 |
| Manufacturer G1 | MOTEK MEDICAL B.V. |
| Manufacturer Street | HOGEHILWEG 18 UNIT C |
| Manufacturer City | AMSTERDAM, NOORD-HOLLAND 1101CD |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 1101CD |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BODY WEIGHT SUPPORT LIGHT |
| Generic Name | POWERED EXERCISER |
| Product Code | BXB |
| Date Received | 2019-04-23 |
| Model Number | RB011 |
| Catalog Number | RB011 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOTEK MEDICAL B.V. |
| Manufacturer Address | HOGEHILWEG 18 UNIT C AMSTERDAM, NOORD-HOLLAND 1101CD NL 1101CD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-23 |