MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-26 for CARDIOCAP/5 CARDIO CAP5 manufactured by Ge Medical Systems Information Technologies, Inc..
[98312690]
Patient Sequence No: 1, Text Type: N, H10
[98312951]
First patient arrived for bilateral si joint injection. Preoperative blood pressure of 140/64 and did not take medication this am. When placed on monitor in operating room the blood pressure ranged from 160/90 to 180/110. Patient was treated with labetol. The second patient preoperative blood pressure was 155/101. When placed in the operating room on the same monitor the blood pressure ranged from 170/100 to 180/128. The second patient was also medicated and the anesthesiologist called for a second monitor and the defective monitor was removed from the or. Both patients were placed in pacu due to receiving labetol and were discharged in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7221058 |
| MDR Report Key | 7221058 |
| Date Received | 2018-01-26 |
| Date of Report | 2018-01-15 |
| Date of Event | 2017-10-09 |
| Report Date | 2017-11-15 |
| Date Reported to FDA | 2017-11-15 |
| Date Reported to Mfgr | 2017-11-15 |
| Date Added to Maude | 2018-01-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOCAP/5 |
| Generic Name | MONITOR, ST SEGMENT WITH ALARM |
| Product Code | MLD |
| Date Received | 2018-01-26 |
| Model Number | CARDIO CAP5 |
| ID Number | B07208 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
| Manufacturer Address | 465 PAN AMERICAN DR. STE. 11 EL PASO TX 79907 US 79907 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-26 |