MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-20 for MAC 5500 HD 018344 manufactured by Ge Medical Systems Information Technologies, Inc.
[117572530]
Patient seen in emergency room with complaints of shortness of breath, diaphoresis, chest pain, and headache. The nurse was attempting to get an ecg, but the mac 5500 hd gave an error message "limb lead disconnected". The nurse replaced the leads and attempted to get an ecg again, but the mac 5500 hd kept giving the same error message. The mac 5500 hd was replaced with another system, and the nurse was able to get an ecg. No untoward patient effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7796619 |
| MDR Report Key | 7796619 |
| Date Received | 2018-08-20 |
| Date of Report | 2018-07-17 |
| Date of Event | 2018-07-15 |
| Report Date | 2018-07-23 |
| Date Reported to FDA | 2018-07-23 |
| Date Reported to Mfgr | 2018-08-20 |
| Date Added to Maude | 2018-08-20 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | MAC 5500 HD |
| Generic Name | ELECTROCARDIOGRAPH |
| Product Code | DPS |
| Date Received | 2018-08-20 |
| Model Number | 5500 HD |
| Catalog Number | 018344 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC |
| Manufacturer Address | 9900 INNOVATION DRIVE WAUWATOSA WI 53226 US 53226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-20 |