FDA Adverse Event
Injury
Summary report: N
SYSTEM 98XT
MDR report key: 3872028
·
Received April 17, 2014
Report
- Report Number
- 2249723-2014-00414
- Event Type
- Injury
- Date Received
- April 17, 2014
- Date of Event
- April 19, 2013
- Report Date
- April 19, 2013
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- PMA / PMN Number
- K961509
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE UNIT WAS TRADED IN FOR A CARDIOSAVE UNIT. THE UNIT, SYSTEM 98-S/N (B)(4) WAS APPROVED TO BE SCRAPPED. INTERNAL FILE: (B)(4).
Description of Event or Problem · 1
TH CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THEY RECEIVED "MAINTENANCE CODE #3 (SHUTTLE TRANSDUCER OFFSET FAILURE) MESSAGE AND "AUTOFILL FAILURE" ALARM DURING THE TRANSPORTATION OF A PATIENT. CYCLED POWER ON THE IABP AND UNIT WAS OKAY. PATIENT WAS SWITCHED TO ANOTHER IABP AT THE RECEIVING HOSPITAL AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235194 | SYSTEM 98XT | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP. | SYSTEM 98XT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |