FDA Adverse Event
Malfunction
Summary report: N
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
MDR report key: 17691614
·
Received September 6, 2023
Report
- Report Number
- 2249723-2023-03933
- Event Type
- Malfunction
- Date Received
- September 6, 2023
- Date of Event
- August 28, 2023
- Report Date
- January 3, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 DEVICE AND STATED THERE IS NO PROBLEM WITH OTHER KEYS. THERE IS NO ALARM LOG NOR FAULT LOG. THE DISPLAY TEST WAS NORMAL, AND NO RECURRENCE AFTER RUNNING TEST. THE FIELD SERVICE ENGINEER (FSE) REINSTALLED THE SOFTWARE (C.06) AND RETURNED IT AFTER CONFIRMING THAT THE SYMPTOMS DID NOT RECUR.
Description of Event or Problem · 0
IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT POWER DID NOT TURN ON.
Description of Event or Problem · 0
N/A
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 713020 | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-0800-65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |