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.
[144975435]
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
[144975436]
As reported, during use on a patient using the hemosphere instrument, after in-vivo calibration and zeroing, the pressure crashed and dropped by about 20mmhg. The system was re-calibrated and re-zeroed and then things came back up and were fine. There was no allegation of patient injury. The device won't be sent back for evaluation. The diagnostic logs were available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-01640 |
| MDR Report Key | 8592202 |
| Date Received | 2019-05-08 |
| Date of Report | 2019-04-19 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 |