FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE G PLUG
MDR report key: 16434954
·
Received February 24, 2023
Report
- Report Number
- 2249723-2023-01257
- Event Type
- Malfunction
- Date Received
- February 24, 2023
- Date of Event
- February 14, 2023
- Report Date
- June 1, 2023
- 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
Additional Manufacturer Narrative · 0
A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE ISSUE. THE FSE CONFIRMED THE POWER CABLE TO BE BROKEN. SO, IN ORDER TO FIX THE ISSUE, THE FSE REPLACED THE AC POWER CORD (0012-00-1688-24). THE UNIT WAS THEN HANDED OVER TO THE CUSTOMER IN GOOD WORKING CONDITION.
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Description of Event or Problem · 0
N/A.
Description of Event or Problem · 0
IT WAS REPORTED THAT PRIOR TO USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS NUH RP CABLE WIRE DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1872020 | 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 | Unknown | N/A. |