MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-21 for GE 5500 EKG MACHINE manufactured by Ge Healthcare.
[109070627]
The patient went up to the icu, where the pa noted the low voltage setting. The cardiac catheterization team was activated, and they found multi-vessel disease. No intervention was performed and the patient was transferred to (b)(6) for evaluation for urgent cabg. As of this moment, i think that is still being done (no surgery yet). Our goal is door-to-balloon of 90 minutes. There was no balloon here, but i think the cath happened at around 180 minutes. There was no intervention, and so i would say there was no resulting harm from the event. The main issue is the ability for a user to change the size of voltage. This can lead to incorrect reading of an ekg. The "little box" is not enough to warn for low voltage settings, and i also wonder if it can be locked or if the warning can be more prominent?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077367 |
| MDR Report Key | 7533916 |
| Date Received | 2018-05-21 |
| Date of Report | 2018-05-17 |
| Date Added to Maude | 2018-05-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 0 |
| Brand Name | GE 5500 EKG MACHINE |
| Generic Name | GE 5500 EKG MACHINE |
| Product Code | DPS |
| Date Received | 2018-05-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-21 |