MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-05-19 for S5 BUBBLE SENSOR MODULE 23-45-00 manufactured by Livanova Deutschland.
[75626767]
(b)(4) manufactures the s5 bubble sensor module. The incident occurred in (b)(6). This medwatch report is being filed on behalf of (b)(4). A (b)(4) field service representative shipped a new bubble sensor to the customer. The customer plans to install the new bubble sensor on their own. The investigation is on-going. 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
[75626768]
(b)(4) received a report that the s5 bubble sensor module alarmed during a procedure when no bubble was present, and that the 1/4" bubble sensor was not recognized. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9611109-2017-00367 |
MDR Report Key | 6580067 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2017-05-19 |
Date of Report | 2017-11-02 |
Date of Event | 2017-04-25 |
Date Mfgr Received | 2017-04-25 |
Device Manufacturer Date | 2016-07-29 |
Date Added to Maude | 2017-05-19 |
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, |
Manufacturer Country | US |
Single Use | 3 |
Remedial Action | OT |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | S5 BUBBLE SENSOR MODULE |
Generic Name | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS |
Product Code | KRL |
Date Received | 2017-05-19 |
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 | 2017-05-19 |