MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-04-20 for S5 SENSOR MODULE FOR BUBBLE DETECTOR 23-45-00 manufactured by Livanova Deutschland.
[106715233]
Livanova (b)(4) manufactures the s5 sensor module for bubble detector. The incident occurred in (b)(6). The device has been requested for return to investigation further. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[106715234]
Livanova (b)(4) received a report that an s5 sensor module for bubble detection did not alarm when a bubble occurred following a change in the setup during a procedure. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611109-2018-00910 |
| MDR Report Key | 7448327 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-04-20 |
| Date of Report | 2018-06-14 |
| Date of Event | 2018-03-19 |
| Date Mfgr Received | 2018-05-03 |
| Device Manufacturer Date | 2013-03-12 |
| Date Added to Maude | 2018-04-20 |
| 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 | 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 SENSOR MODULE FOR BUBBLE DETECTOR |
| Generic Name | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS |
| Product Code | DTW |
| Date Received | 2018-04-20 |
| Model Number | 23-45-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2018-04-20 |