MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-26 for CS300 N/A 0998-00-3023-53 manufactured by Datascope Corp. - Mahwah.
[185523371]
The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event. A getinge service territory manager (stm) was dispatched to evaluate the iabp unit and found that the unit was full of moisture and the transducers were out of calibration. Stm removed the transducers and cleaned them. One had vacuum grease and water behind it. The fse performed the transducer calibrations and once calibrations passed, a complete system checkout was done. The iabp passed all testing, returned to the customer and cleared for clinical use.
Patient Sequence No: 1, Text Type: N, H10
[185523372]
It was reported by customer that cs300 intra-aortic balloon pump (iabp) displayed required maintenance (code # 3). It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249723-2020-00484 |
| MDR Report Key | 9886151 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2002-02-01 |
| Date Added to Maude | 2020-03-26 |
| 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 Street | 1300 MACARTHUR BLVD |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer G1 | DATASCOPE CORP. - MAHWAH |
| Manufacturer Street | 1300 MACARTHUR BLVD |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CS300 |
| Generic Name | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL |
| Product Code | DSP |
| Date Received | 2020-03-26 |
| Model Number | N/A |
| Catalog Number | 0998-00-3023-53 |
| Lot Number | N/A |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATASCOPE CORP. - MAHWAH |
| Manufacturer Address | 1300 MACARTHUR BLVD MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |