MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-09-14 for BURDICK T600 TREADMILL 92401 NA manufactured by Cardiac Science Corporation.
[1768829]
Customer stated they had just started the treadmill at minimum speed. The patient stepped on the treadmill and a short time later the treadmill sped up to maximum speed. At some point the patient fell off the treadmill. Patient reported some minor soreness. The doctors checked her over several times and said she was okay. Patient refused any further treatment.
Patient Sequence No: 1, Text Type: D, B5
[8689539]
Cardiac science field service engineer was dispatched to the site. He replaced a treadmill control board and interface cable. The system was tested twice in a bruce protocol with no problems found. A functional test was also completed. The original parts are being returned to the manufacturer. When further information becomes available a follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3014398-2010-00029 |
| MDR Report Key | 1873609 |
| Report Source | 05,06 |
| Date Received | 2010-09-14 |
| Date of Report | 2010-08-16 |
| Date of Event | 2010-08-16 |
| Date Mfgr Received | 2010-08-19 |
| Device Manufacturer Date | 2004-05-01 |
| Date Added to Maude | 2011-05-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BEV MAGRANE |
| Manufacturer Street | 3303 MONTE VILLA PKWY. |
| Manufacturer City | BOTHELL WA 98028 |
| Manufacturer Country | US |
| Manufacturer Postal | 98028 |
| Manufacturer Phone | 4254022365 |
| Manufacturer G1 | CARDIAC SCIENCE CORPORATION |
| Manufacturer Street | 500 BURDICK PARKWAY |
| Manufacturer City | DEERFIELD WI 53531 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53531 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BURDICK T600 TREADMILL |
| Generic Name | CARDIAC STRESS TESTING TREADMILL |
| Product Code | IOL |
| Date Received | 2010-09-14 |
| Model Number | 92401 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIAC SCIENCE CORPORATION |
| Manufacturer Address | 3303 MONTE VILLA PKWY. BOTHELL WA 98028 US 98028 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-14 |