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.
[185920437]
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
[185920438]
It was reported that during intra-aortic balloon (iab) therapy, the console displayed negative numbers for blood pressure and the waveform was dampened. The customer rezeroed while pumping, and tried disconnecting the fo connector and reconnect with the same results. A flush bag was in place with a transducer and advised him to aspirate to check the lumen for patency. A blood return was present and the customer then flushed for 10 -15 seconds and rezeroed with the same results. At this point, the fo was disconnected and a good waveform was present on the screen from the transducer. He zeroed this and reports better numbers. The call ended and the patient is being monitored via the central lumen of the balloon catheter. There was no reported injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2248146-2020-00181 |
| MDR Report Key | 9903864 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-11-25 |
| 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 |
| 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 | 3000109691 |
| 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 |