MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-12-22 for MAC 800 manufactured by Ge Medical Systems China Co., Ltd..
[2398073]
The hospital reported an electrocardiogram (ecg) was completed on a pt being treated in the emergency ward. To print the ecg, the user did not use the green ecg key on the mac 800 keyboard for printing out the current ecg, but instead used the function keys which are used to print out the ecg for the previous pt. The ecg for the previous pt indicated cardiac distress. Subsequently, it was reported that the pt that had the ecg in the emergency ward was taken for a cardiac catheterization after a clinician reviewed the ecg printout that was completed on the previous pt. There was no further sequelae reported. Ge healthcare's investigation is ongoing. A follow up report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5
[9683206]
Under (b)(6) law, pt information is considered confidential and will not be released by the site.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710602-2011-00005 |
| MDR Report Key | 2393997 |
| Report Source | 01,05,06 |
| Date Received | 2011-12-22 |
| Date of Report | 2011-11-29 |
| Date of Event | 2011-11-28 |
| Date Mfgr Received | 2011-11-28 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2012-01-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOY SONSALLA |
| Manufacturer Street | 3000 N GRANDVIEW BLVD W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | GE MEDICAL SYSTEMS CHINA CO., LTD |
| Manufacturer City | WUXI, JIANGSU |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAC 800 |
| Generic Name | ELECTROCARDIOGRAPH ANALYSIS SYSTEM |
| Product Code | LOS |
| Date Received | 2011-12-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS CHINA CO., LTD. |
| Manufacturer Address | WUXI, JIANGSU CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-12-22 |