MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-28 for S5 BUBBLE DETECTOR SENSOR, LOW LEVEL II 23-27-40 manufactured by Livanova Deutschland.
[131912181]
Serial number is unknown. This information will be provided in a supplemental report if made available. As the serial number is unknown, the device manufacture date could not be determined. This information will be provided in a supplemental report if made available. Livanova (b)(4) manufactures the s5 bubble detector sensor, low level ii. The incident occurred in (b)(6). If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[131912182]
Livanova (b)(4) received a report that a s5 bubble detector sensor, low level ii was spontaneously overridden during the procedure and the reservoir dropped below the set point. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611109-2018-01442 |
| MDR Report Key | 8202253 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-28 |
| Date of Report | 2018-12-28 |
| Date of Event | 2018-11-29 |
| Date Mfgr Received | 2018-11-30 |
| Date Added to Maude | 2018-12-28 |
| 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 | JOAN CEASAR |
| Manufacturer Street | 14401 W. 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Manufacturer Phone | 2812287260 |
| Manufacturer G1 | LIVANOVA DEUTSCHLAND |
| Manufacturer Street | LINDBERGHSTR. 25 |
| Manufacturer City | MUNICH 80939 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 80939 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S5 BUBBLE DETECTOR SENSOR, LOW LEVEL II |
| Generic Name | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS |
| Product Code | DTW |
| Date Received | 2018-12-28 |
| Model Number | 23-27-40 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIVANOVA DEUTSCHLAND |
| Manufacturer Address | LINDBERGHSTR. 25 MUNICH 80939 GM 80939 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-28 |