FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 19249336
·
Received May 6, 2024
Report
- Report Number
- 2249723-2024-01840
- Event Type
- Malfunction
- Date Received
- May 6, 2024
- Date of Event
- April 24, 2024
- Report Date
- September 18, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
UPDATED DATA: B4, G3, G6, H2, H10, H11.
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Additional Manufacturer Narrative · 0
A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND WAS ABLE TO DUPLICATE THE REPORTED MALFUNCTION. THE FSE REPLACED THE NON-APPROVED PAPER WITH OEM CHART RECORDER PAPER (0683-00-0422). THE FSE PRINTED 5 PATIENT STRIPS WITH NO ERRORS OR ISSUES. THE FSE PERFORMED AN INSPECTION AND FUNCTIONAL CHECKOUT. THE IABP WAS RETURNED TO SERVICE.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS PRINTER ISSUES. THERE WAS NO HARM REPORTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS PRINTER ISSUES. THERE WAS NO HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 613711 | CARDIOSAVE HYBRID, TYPE B PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-0800-53 | 10607567108391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |