MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-10-06 for CARDIOCAP 5 manufactured by Ge Healthcare Finland, Oy.
[1838062]
A nurse reportedly discovered towards the end of the case that the pt's face was blue. The anesthesiologist was notified and proceeded to administer medication (e. G. Epinephrine), intubated the pt, connected the pt to the anesthesia machine and ventilated the pt both manually and mechanically. Resuscitation measures are said to have taken approx 45 mins. It is alleged that the cardiocap 5 monitor did not alarm during the event. Following the event, the pt reportedly remained unconscious and was transferred to another medical center, where she said to be improving.
Patient Sequence No: 1, Text Type: D, B5
[8685950]
The device manufacture date is unk. The device was shipped on 12/11/2005. Prior to ge healthcare's arrival for the onsite investigation, the monitor had been turned off by hospital staff, therefore, no trend data was available for analysis. During ge healthcare's onsite investigation, initial inspection of the monitor revealed the alarm volume was set to the default setting of 2. Testing was conducted on the monitor, including simulated alarm conditions, and the unit was found to operate according to mfr's specifications. Additionally, the blood pressure cuff was connected to a hospital staff member, with the monitor set to take a blood pressure every min. This testing lasted 10 mins, and the monitor was found to operate as designed. Subsequent to ge healthcare's investigation, the hospital reported they will request an independent party perform a checkout on the monitor. Until that occurs, the hospital reported, the equipment and operating room will remain in quarantine. Ge healthcare's investigation of the monitor found the unit to function according to the mfg specifications. The reported complaint could not be duplicated. As hospital staff turned the monitor off following the case, the trend data for the case cannot be evaluated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610105-2010-00017 |
| MDR Report Key | 1869497 |
| Report Source | 05,06 |
| Date Received | 2010-10-06 |
| Date of Report | 2010-10-06 |
| Date of Event | 2010-09-08 |
| Date Mfgr Received | 2010-09-08 |
| Date Added to Maude | 2010-10-25 |
| 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 | DEBRA LAHR |
| Manufacturer Street | 540 W NORTHWEST HWY |
| Manufacturer City | BARRINGTON IL 600103076 |
| Manufacturer Country | US |
| Manufacturer Postal | 600103076 |
| Manufacturer Phone | 8472774472 |
| 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 | CONFIGURED MONITORS |
| Product Code | MLD |
| Date Received | 2010-10-06 |
| ID Number | X-ANE01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE FINLAND, OY |
| Manufacturer Address | HELSINKI FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2010-10-06 |