MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-12-20 for CARDIOCAP 5 manufactured by Ge Healthcare Finland Oy.
[2502250]
It was reported that preventative maintenance had recently been done on the cardiocap 5 by hospital staff or hospital biomed and the audible alarm was not alarming for sp02. All other functions were reportedly normal. Ge technical support attempted to resolve the issue but the hospital requested a ge field service dispatch. There was no report of 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
| Report Number | 9610105-2011-00025 |
| MDR Report Key | 2387858 |
| Report Source | 05,06 |
| Date Received | 2011-12-20 |
| Date of Report | 2011-04-04 |
| Date of Event | 2011-04-04 |
| Date Mfgr Received | 2011-04-04 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2012-04-18 |
| 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 SONSALL |
| 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 | CARDIOCAP 5 |
| Generic Name | MULTI-PARAMETER PATIENT MONITOR |
| Product Code | MLD |
| Date Received | 2011-12-20 |
| 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 | 2011-12-20 |