CARDIOSAVE HYBRID, TYPE G PLUG
Report
- Report Number
- 2249723-2026-0000884
- Event Type
- Malfunction
- Date Received
- January 27, 2026
- Date of Event
- January 5, 2026
- Report Date
- April 14, 2026
- Manufacturer
- DATASCOPE CORP.
- 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,G3, G6, H3, H11. AFTER FURTHER REVIEW, AN INITIAL EMDR FOR THIS COMPLAINT WAS INCORRECTLY SUBMITTED. THE COMPLAINT WAS CREATED IN ERROR, THE SAFETY DISK WAS DUE FOR REPLACEMENT , THERE WAS NO REPORTED CUSTOMER DISSATISFACTION RELATED TO THIS EVENT, MAKING IT NON-REPORTABLE TO THE FDA. AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL IN YOUR DATABASE.
UPDATED DATA: B4, G3, G6, H1, H2, H11. CORRECTED DATA: H6 (TYPE OF INVESTIGATION).
UPDATED FIELDS: B4, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODE, CONCLUSION), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE (FSE) CONFIRMED THE FAILURE AND REPLACED THE SAFETY DISK. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS AS PER FACTORY SPECIFICATIONS.
AS PER THE INFORMATION PROVIDED BY GETINGE (FIELD SERVICE ENGINEER) FSE, THIS RECORD IS REPORTABLE. KINDLY DISREGARD THE PREVIOUS REPORT NUMBER 2249723-2026-0000884. WHICH WAS SENT IN ERROR.
IT WAS REPORTED THAT, DURING A ROUTINE CUSTOMER CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP GENERATED A ¿SAFETY DISK REPLACEMENT¿ MESSAGE. THERE WAS NO PATIENT INVOLVED AT THE TIME.
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Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250048 | CARDIOSAVE HYBRID, TYPE G PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-52 | 10607567108438 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |