MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-26 for MAC 5500 HD manufactured by Ge Medical Systems Information Technologies.
[125129680]
Failure of part number 2031810-002 fru universal writer (lower case of the unit). This failure has lead to other damage including the unit will power on but the display is blank, the bottom case where the unit attaches to the trolley is cracked, the cover of the key board is cracked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8008708 |
| MDR Report Key | 8008708 |
| Date Received | 2018-10-26 |
| Date of Report | 2018-10-18 |
| Date of Event | 2018-10-08 |
| Report Date | 2018-10-18 |
| Date Reported to FDA | 2018-10-18 |
| Date Reported to Mfgr | 2018-10-26 |
| Date Added to Maude | 2018-10-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-10-26 |
| Model Number | MAC 5500 HD |
| Device Availability | Y |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| Manufacturer Address | 8200 W TOWER AVE MILWAUKEE WI 53223 US 53223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-26 |