MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-10-21 for QUINTON TM55 TREADMILL TM55LXXRCE NA manufactured by Cardiac Science Corporation.
[1664194]
During stage one of a stress test protocol, customer stated the treadmill sped up on its own and the patient was thrown from the treadmill. The patient received a minor scrape on the knee.
Patient Sequence No: 1, Text Type: D, B5
[8920292]
Field service engineer was dispatched to the site and checked the entire system including internal connections within the treadmill and stress monitor. System log files were also gathered and sent in for evaluation. Several errors related to the treadmill were observed. As a precaution the field service engineer replaced the main treadmill circuit board and drive motor. The treadmill circuit board was returned to cardiac science corporation for investigation. It was installed in a test fixture and tested extensively with no problems found. All tests passed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3014398-2010-00033 |
| MDR Report Key | 1889177 |
| Report Source | 05 |
| Date Received | 2010-10-21 |
| Date of Report | 2010-09-28 |
| Date of Event | 2010-09-28 |
| Date Mfgr Received | 2010-09-28 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2011-02-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BEV MAGRANE |
| Manufacturer Street | 3303 MONTE VILLA PARKWAY |
| 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 | QUINTON TM55 TREADMILL |
| Generic Name | CARDIAC STRESS TESTING TREADMILL |
| Product Code | IOL |
| Date Received | 2010-10-21 |
| Returned To Mfg | 2010-10-14 |
| Model Number | TM55LXXRCE |
| 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 PARKWAY BOTHELL WA 98028 US 98028 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-21 |