MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-04-14 for QUINTON CR60 TREADMILL 000380-001 manufactured by Cardiac Science Corporation.
[18904971]
Customer requested field service engineer (fse) dispatch to check out the treadmill prior to using again. Fse performed preventative maintenance which included a mechanical and electrical safety check. Fse found no problems with the treadmill. During his investigation, the fse found the magnetic key for emergency stopping was activated, but was not utilized for the patient. In order for the key to assist in emergency stopping, it must be enabled and attached to the patient.
Patient Sequence No: 1, Text Type: N, H10
[19055684]
In 2009, customer called to inform cardiac science that a patient fell off their treadmill while using it in a cardiac rehab setting. Customer stated they did not believe the treadmill was at fault but requested a field service engineer dispatch to check out the unit prior to using again. The patient fell off the treadmill and sustained bruising and scraping to the knees, legs and face which resulted in some blackening around the eyes. This patient was checked into the emergency room to be evaluated. It was suggested that her fall may have been the result of a black out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014398-2009-00014 |
| MDR Report Key | 1363088 |
| Report Source | 05,06 |
| Date Received | 2009-04-14 |
| Date of Report | 2009-04-14 |
| Date of Event | 2009-03-16 |
| Date Mfgr Received | 2009-03-16 |
| Device Manufacturer Date | 1997-04-01 |
| Date Added to Maude | 2009-04-20 |
| 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 98021 |
| Manufacturer Country | US |
| Manufacturer Postal | 98021 |
| Manufacturer Phone | 4254022365 |
| Manufacturer G1 | CARDIAC SCIENCE CORPORATION |
| Manufacturer Street | 500 BURDICK PKWY |
| Manufacturer City | DEERFIELD WI 53531969 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53531 9692 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUINTON CR60 TREADMILL |
| Generic Name | REHAB TREADMILL |
| Product Code | ISD |
| Date Received | 2009-04-14 |
| Model Number | 000380-001 |
| 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 | BOTHELL WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-04-14 |