MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-10 for E-COVX manufactured by Ge Healthcare Finland Oy.
[15207416]
The hospital reported the e-covx module was damaged during intra hospital transport. The customer stated, "the latch wasn't holding it fell out and sustained physical damage. " visual inspection by the ge field service engineer revealed a crack to the upper left side of the front housing and a chip in the lower right side of the front housing that did not effect module operation. There was no patient involvement. 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
[15749812]
This device is intended to be a mobile unit affixed to a bedrail or stand proximal to the patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610105-2012-00021 |
| MDR Report Key | 2579753 |
| Report Source | 05,06 |
| Date Received | 2012-05-10 |
| Date of Report | 2012-04-10 |
| Date of Event | 2002-04-10 |
| Date Mfgr Received | 2012-04-10 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2012-09-20 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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. |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | GE HEALTHCARE FINLAND OY |
| Manufacturer City | HELSINKI |
| Manufacturer Country | FI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-COVX |
| Generic Name | PARAMETER MODULES |
| Product Code | CCL |
| Date Received | 2012-05-10 |
| 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 FINLAND OY |
| Manufacturer Address | HELSINKI FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-10 |