MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-05-03 for CARDIOSOFT / CASE CARDIAC TESTING SYSTEM 2012492-003 * manufactured by Ge Healthcare.
[16708083]
Customer reported patient stumbled during testing. Hospital personnel reportedly pressed the recovery button and the unit went faster. There was no reported patient injury. Investigation/conclusion: according to the customer, the user mistakenly pressed the excercise key instead of the recovery key.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613557-2007-00006 |
| MDR Report Key | 962553 |
| Report Source | 05 |
| Date Received | 2007-05-03 |
| Date of Report | 2007-05-03 |
| Date of Event | 2007-04-04 |
| Date Mfgr Received | 2007-04-04 |
| Device Manufacturer Date | 2004-12-01 |
| Date Added to Maude | 2007-12-13 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | ANN LEBAR |
| Manufacturer Street | MAIL STOP: RP2138 |
| Manufacturer City | WAUWATOSA WI 53226 |
| Manufacturer Country | US |
| Manufacturer Postal | 53226 |
| Manufacturer Phone | 4147213947 |
| Manufacturer G1 | GE HEALTHCARE |
| Manufacturer Street | * |
| Manufacturer City | JUAREZ |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOSOFT / CASE CARDIAC TESTING SYSTEM |
| Generic Name | CARDIOVASCULAR ECG ANALYSIS SYSTEM |
| Product Code | LOS |
| Date Received | 2007-05-03 |
| Model Number | 2012492-003 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | SOFTWARE 5.15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 932628 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | * JUAREZ MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-03 |