MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-08 for HEMOSPHERE INSTRUMENT MONITOR HEM1 manufactured by Edwards Lifesciences.
[144732768]
The product is not expected to be returned for analysis; however, the diagnostic logs are expected to be received. Upon the return of the diagnostic logs a supplemental report will be sent with the investigation results as well as the device history record. Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
Patient Sequence No: 1, Text Type: N, H10
[144732769]
As reported, during a mitral valve replacement plus cabbage, using this hemosphere instrument, issues were found after zeroing the system with sending the pressure signal out. The clinician observed discrepancies between the philips monitor and the hemosphere instrument. The trends were not matching and the readings were off by 20mmhg. The philips monitor was zeroed first and then the hemosphere was zeroed. Troubleshooting with zeroing and sending the signal out were successful and then the values matched. The trends were still looking a bit different, but the trend scales were changed and then they were fine. There was no allegation of patient injury. The device was not available for evaluation. The diagnostic logs were available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-01639 |
| MDR Report Key | 8592178 |
| Date Received | 2019-05-08 |
| Date of Report | 2019-04-18 |
| Date of Event | 2019-04-18 |
| Date Mfgr Received | 2019-06-28 |
| Device Manufacturer Date | 2018-06-11 |
| Date Added to Maude | 2019-05-08 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SAMANTHA EVELEIGH |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492503939 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEMOSPHERE INSTRUMENT MONITOR |
| Generic Name | COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION |
| Product Code | DXG |
| Date Received | 2019-05-08 |
| Model Number | HEM1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-08 |