MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-05-28 for QUINTON TM55 TREADMILL 000489-009 manufactured by Cardiac Science Corporation.
[1538458]
Customer stated that during a stress test, the pt requested the treadmill to be slowed down. The end user slowed the treadmill and attempted to stop the treadmill belt but it was non-responsive. The pt fell from the treadmill and was taken to the emergency room to be evaluated. The extent of the injuries is unk.
Patient Sequence No: 1, Text Type: D, B5
[8550327]
Csc field service engineer was dispatched on-site to evaluate the treadmill and stress testing sys. The sys was tested several times and the problem could not be duplicated. As a precaution, the treadmill interface cable was replaced. Log files from the sys were also sent in for eval but they were incomplete and nothing that would contribute to the investigation was logged. No evidence there was a device problem, this could have been user error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3014398-2010-00016 |
| MDR Report Key | 1708444 |
| Report Source | 06 |
| Date Received | 2010-05-28 |
| Date of Report | 2010-05-26 |
| Date of Event | 2010-04-29 |
| Date Mfgr Received | 2010-04-29 |
| Device Manufacturer Date | 2002-12-01 |
| Date Added to Maude | 2010-06-23 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | DEERFIEDL 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 | 2010-05-28 |
| Model Number | 000489-009 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2010-05-28 |