MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-05-20 for OMNICYCLE 01034-000 manufactured by Medica Medizintechnik Gmbh.
[5858461]
On (b)(6) 2015 acp was notified of event. Pt was seated at the omnicycle with feet flat on the floor. The therapist noted that the display was dark. She then noticed that the cycle was not plugged into wall power. The therapist reported that the moment she plugged the cycle in, the lower extremity pedals began to rotate, cutting the pt's left calf. The pt sustained a laceration on her left calf, which required 14 stitches.
Patient Sequence No: 1, Text Type: D, B5
[13404293]
Upon questioning, the therapist stated that she could not duplicate the problem. Investigation/eval of the cycle resulted in unable to duplicate the reported issue. In accordance with the user manual, the cycle defaults to the neuro mode of operation unless this has been changed in the program selection menu; therefore, when the start button is pressed, the lower extremity exercise will begin.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1911273-2015-00001 |
| MDR Report Key | 4796008 |
| Report Source | 06 |
| Date Received | 2015-05-20 |
| Date of Report | 2015-05-05 |
| Date of Event | 2015-04-29 |
| Date Facility Aware | 2015-04-29 |
| Report Date | 2015-05-05 |
| Date Reported to FDA | 2015-05-05 |
| Date Reported to Mfgr | 2015-05-05 |
| Device Manufacturer Date | 2009-10-19 |
| Date Added to Maude | 2015-05-27 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | BLUMENWEG 8 |
| Manufacturer City | HOCKDORF 88454 |
| Manufacturer Country | GM |
| Manufacturer Postal | 88454 |
| Manufacturer Phone | 35593140 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNICYCLE |
| Product Code | BXB |
| Date Received | 2015-05-20 |
| Model Number | 01034-000 |
| ID Number | 1034-000-0109415094 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 78 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICA MEDIZINTECHNIK GMBH |
| Manufacturer Address | BLUMENWEG 8 HOCKDORF 88454 GM 88454 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-05-20 |