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 2011-04-14 for MICROSMART manufactured by Ge Healthcare.
[21349923]
The month of manufacture is not known at this time. This device was originally manufactured in (b)(4) but the facility no longer manufactures devices.
Patient Sequence No: 1, Text Type: N, H10
[21410859]
It was reported that a nurse was performing an electrocardiograph (ecg) when she smelled a faint burning scent. She went on to perform 2 more ecgs and the smell increased. The unit was switched off and a technician was called to check the device. The technician turned to unit back on 5 minutes later and noticed visible smoke coming from the device. The unit was switched off and the battery removed. The battery was reported to be near room temperature. After a few minutes, a blister formed on the plastic housing near the ecg cable connection. The blister developed into a blackened hole. The unit's motherboard was visibly hot. There were no injuries 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
| Report Number | 2124823-2011-00041 |
| MDR Report Key | 2081135 |
| Report Source | 01,05,06 |
| Date Received | 2011-04-14 |
| Date of Report | 2011-04-14 |
| Date of Event | 2011-03-16 |
| Date Mfgr Received | 2011-03-16 |
| Device Manufacturer Date | 1998-01-01 |
| Date Added to Maude | 2011-07-13 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 HEALTHCARE |
| Manufacturer City | MILWAUKEE WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROSMART |
| Generic Name | ECG ANALYSIS SYSTEM |
| Product Code | LOS |
| Date Received | 2011-04-14 |
| 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 HEALTHCARE |
| Manufacturer Address | MILWAUKEE WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-14 |