MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for SENSATION PLUS 8FR. 50CC 0684-00-0575 manufactured by Datascope Corp. - Fairfield.
[185921101]
The device has not been returned to the manufacturer so we are unable to complete an evaluation. If provided we will send a supplemental report with our additional findings. Complaint record id # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185921102]
It was reported that during intra-aortic balloon (iab) therapy, the iab would not flush and the customer could not get blood return. There was no reported injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2248146-2020-00183 |
| MDR Report Key | 9905047 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-13 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2019-11-07 |
| Date Added to Maude | 2020-03-31 |
| 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 | MS. DOROTA WOLPIUK |
| Manufacturer Street | 15 LAW DRIVE |
| Manufacturer City | FAIRFIELD NJ 07004 |
| Manufacturer Country | US |
| Manufacturer Postal | 07004 |
| Manufacturer G1 | DATASCOPE CORP. - FAIRFIELD |
| Manufacturer Street | 15 LAW DRIVE |
| Manufacturer City | FAIRFIELD NJ 07004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSATION PLUS 8FR. 50CC |
| Generic Name | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL |
| Product Code | DSP |
| Date Received | 2020-03-31 |
| Catalog Number | 0684-00-0575 |
| Lot Number | 3000108620 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATASCOPE CORP. - FAIRFIELD |
| Manufacturer Address | 15 LAW DRIVE FAIRFIELD NJ 07004 US 07004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |