MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-27 for GE MEDICAL SYSTEMS 2024315-001 NOT APPLICABLE manufactured by .
[68368655]
Patient Sequence No: 1, Text Type: N, H10
[68368656]
Stress test completed. Clock is off by 10 minutes on treadmill. This is a reoccurring problem. Clock has been corrected several times.
Patient Sequence No: 1, Text Type: D, B5
[96760614]
Unique device identifier (udi): for type of device: ge medical systems treadmill t2100
Patient Sequence No: 1, Text Type: N, H10
[96760615]
Stress test completed. Clock is off by 10 minutes on treadmill. This is a reoccurring problem. Clock has been corrected several times.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6360105 |
| MDR Report Key | 6360105 |
| Date Received | 2017-02-27 |
| Date of Report | 2017-02-22 |
| Date of Event | 2017-01-24 |
| Report Date | 2017-02-14 |
| Date Reported to FDA | 2017-02-14 |
| Date Reported to Mfgr | 2017-02-14 |
| Date Added to Maude | 2017-02-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GE MEDICAL SYSTEMS |
| Generic Name | GE MEDICAL SYSTEMS TREADMILL T2100 |
| Product Code | IOL |
| Date Received | 2017-02-27 |
| Model Number | 2024315-001 |
| Catalog Number | NOT APPLICABLE |
| Lot Number | NOT APPLICABLE |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer Address | 8200 W TOWER AVE MILWAUKEE WI 53223 US 53223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-27 |