MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-26 for CARESCAPE B450 manufactured by Ge.
[53784734]
Asking for an ek-pro algorithm review, because it took the system 9 seconds to alarm asystole after the last qrs beat. There was a 3 second pause arrhythmia preceding the last qrs beat. Using the 1500 method that pause would equal a hr of 20 bpm. If you take into account this 3 second pause right before the last qrs beat, it took the system 12 seconds to alarm asystole. Cscs s/n is (b)(4), b450 s/n is (b)(4), fh transmitter s/n is (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064439 |
| MDR Report Key | 5917224 |
| Date Received | 2016-08-26 |
| Date of Report | 2016-08-26 |
| Date of Event | 2016-07-18 |
| Date Added to Maude | 2016-08-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CARESCAPE B450 |
| Generic Name | CARESCAPE B450 |
| Product Code | MHX |
| Date Received | 2016-08-26 |
| Model Number | B450 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE |
| Brand Name | APEX FH TRANSMITTER |
| Generic Name | APEX FH TRANSMITTER |
| Product Code | DXH |
| Date Received | 2016-08-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | GE |
| Brand Name | CARESCAPE CENTRAL STATION |
| Generic Name | CARESCAPE CENTRAL STATION |
| Product Code | DXJ |
| Date Received | 2016-08-26 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | GE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-26 |