CARDIOSAVE HYBRID, TYPE G PLUG
Report
- Report Number
- 2249723-2022-03148
- Event Type
- Malfunction
- Date Received
- December 9, 2022
- Date of Event
- November 28, 2022
- Report Date
- February 24, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108438
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
UPDATED FIELDS - B4, D9, E1(SITE COUNTRY), G3, G6, H2, H3, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H10, H11. CORRECTED FIELDS: (B)(6). ADDITIONAL INFORMATION: E1(EVENT SITE POSTAL CODE: (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE IABP UNIT WHICH WAS HAVING PNEUMATIC MODULE TEST FAIL ISSUE. TO FIX THIS ISSUE FSE REPLACED NEW SAFETY DISK. ALL MANIFOLD TEST PASSED. ALL FUNCTIONAL SAFETY CHECKS HAVE BEEN MADE TO MEET FACTORY SPECIFICATIONS. THE IABP RETURNED TO THE CUSTOMER FOR USE.
IT WAS REPORTED THAT DURING PREPARATION, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) NHC RP ERROR OCCURRED DURING PNEUMATIC MODULE TEST.
IT WAS REPORTED THAT DURING PREPARATION, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) NHC RP ERROR OCCURRED DURING PNEUMATIC MODULE TEST. THERE WAS NO PATIENT INVOLVEMENT
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2842247 | CARDIOSAVE HYBRID, TYPE G PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-0800-52 | 10607567108438 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | N/A.| UNKNOWN. |