MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-14 for EM-TEC PEDIATRIC FLOW PROBE 201-30105 manufactured by Thoratec Switzerland Gmbh.
[180194600]
No further information was provided. A supplemental report will be submitted when the manufacturer? S investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[180194601]
It was reported that there was a flow of 0. 47 lpm when the centrimag (cmag) system was not turned on and there is no flow. The cmag flow probe was connected to a backup cmag system, and the problem continued. The flow probe was then switched with the a different flow probe with the same console. This resolved the issue.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2916596-2020-00838 |
MDR Report Key | 9713050 |
Report Source | COMPANY REPRESENTATIVE,DISTRI |
Date Received | 2020-02-14 |
Date of Report | 2020-02-14 |
Date of Event | 2020-01-27 |
Date Mfgr Received | 2020-01-27 |
Date Added to Maude | 2020-02-14 |
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 | MR. BOB FRYC |
Manufacturer Street | 6035 STONERIDGE DRIVE |
Manufacturer City | PLEASANTON CA 94588 |
Manufacturer Country | US |
Manufacturer Postal | 94588 |
Manufacturer Phone | 7818528204 |
Manufacturer G1 | THORATEC SWITZERLAND GMBH |
Manufacturer Street | TECHNOPARKSTRASSE 1 |
Manufacturer City | ZURICH CH-8005 |
Manufacturer Country | SZ |
Manufacturer Postal Code | CH-8005 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | EM-TEC PEDIATRIC FLOW PROBE |
Generic Name | CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS |
Product Code | DWA |
Date Received | 2020-02-14 |
Model Number | 201-30105 |
Catalog Number | 201-30105 |
Lot Number | 6480352 |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | THORATEC SWITZERLAND GMBH |
Manufacturer Address | TECHNOPARKSTRASSE 1 ZURICH CH-8005 SZ CH-8005 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-02-14 |