MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-16 for CARDIOCAP 5 manufactured by Ge Healthcare Finland.
[17140220]
The customer reports the cardiocap 5 was being moved and bumped into something causing the monitor to fall forward, however, it was caught by staff. The staff reports the mounting clip that holds the device in place was missing, though the clip was present when installed. There was no reported pt injury associated with this event. A follow-up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610105-2012-00029 |
| MDR Report Key | 2705417 |
| Report Source | 05,06 |
| Date Received | 2012-08-16 |
| Date of Report | 2012-07-19 |
| Date of Event | 2012-07-19 |
| Date Mfgr Received | 2012-07-19 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2012-12-04 |
| 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 |
| 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 FINLAND |
| Manufacturer City | OY, 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 | 2012-08-16 |
| 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 |
| Manufacturer Address | OY, HELSINKI FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-16 |