MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-09-27 for OMNICYCLE ELITE A000-533 NA manufactured by Accelerated Care Plus.
[21875702]
Acp was made aware of the pt related incident on (b)(6) 2013. Cycle pedals were removed per request for one bariatric pt, and upon completion of exercise pedals were requested to be left off since the therapy gym uses only the upper extremity exerciser for this omnicycle. A week later, a nurse went into therapy room and accidentally unplugged the omnicycle when attempting to medicate pt who was using the omnicycle for upper extremity exercise. When omnicycle was plugged back in, the pt pressed the start button causing the cycle to default to lower extremity exercise and the lower extremity crank arms rotated, cutting her lower right leg. The facility reported that the pt did not have feeling in her lower extremities prior to the incident. Therefore, she did not know she was cut until blood was seen. Pt was sent to er and received staples to close the cut.
Patient Sequence No: 1, Text Type: D, B5
[21912502]
The lower extremity pedals were removed from the crank arm to fit a bariatric pt during the prior week for upper extremity exercise. The therapist's intentions were to continue to use the omnicycle as an upper extremity only cycle. During the event, a nurse unplugged the device. This resets the device to its lower extremity default configuration on the next power up event. When the cycle was reset, the therapist would typically change the default from lower extremity to upper extremity per pt treatment plan. However, the pt pressed start button on the power up event, prior to the therapist being able to change the exerciser to upper extremity exercise. The start button caused the cycle to begin lower extremity exercise, even though the lower extremity pedals had been removed. The lower extremity crank arm rotated and came in contact with the pt's right lower leg. The result was a skin tear.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1911273-2013-00001 |
| MDR Report Key | 3570563 |
| Report Source | 06 |
| Date Received | 2013-09-27 |
| Date of Report | 2013-09-26 |
| Date of Event | 2013-08-28 |
| Date Facility Aware | 2013-09-04 |
| Report Date | 2013-09-25 |
| Date Reported to FDA | 2013-09-26 |
| Date Reported to Mfgr | 2013-09-20 |
| Date Mfgr Received | 2010-12-10 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2014-01-14 |
| 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 | HOCHDORF D-88454 |
| Manufacturer Country | GM |
| Manufacturer Postal | D-88454 |
| Manufacturer Phone | 35593140 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNICYCLE ELITE |
| Generic Name | POWERED EXERCISER / ERGOMETER |
| Product Code | BXB |
| Date Received | 2013-09-27 |
| Returned To Mfg | 2013-09-04 |
| Model Number | A000-533 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCELERATED CARE PLUS |
| Manufacturer Address | 4850 JOULE STREET RENO NV 89502 US 89502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-09-27 |