MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for TRANS-RAY 7FR. 40CC 0684-00-0514 manufactured by Datascope Corp. - Fairfield.
[185517466]
Event site postal code - (b)(4). 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 # 301606.
Patient Sequence No: 1, Text Type: N, H10
[185517467]
It was reported during intra-aortic balloon (iab) therapy, the console generated an iab circuit leak alarm frequently. The connection was confirmed, and it was confirmed that there were no kinks outside or inside the body. The balloon was replaced to continue therapy and the alarm was resolved. There was no reported injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2248146-2020-00176 |
| MDR Report Key | 9897702 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2018-06-08 |
| Date Added to Maude | 2020-03-30 |
| 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 | TRANS-RAY 7FR. 40CC |
| Generic Name | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL |
| Product Code | DSP |
| Date Received | 2020-03-30 |
| Catalog Number | 0684-00-0514 |
| Lot Number | 3000075135 |
| 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 | 2020-03-30 |