FDA Adverse Event
Malfunction
Summary report: N
CS100
MDR report key: 3031051
·
Received March 28, 2013
Report
- Report Number
- 2249723-2013-00013
- Event Type
- Malfunction
- Date Received
- March 28, 2013
- Date of Event
- January 4, 2013
- Report Date
- January 4, 2013
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REP WAS UNABLE TO REPRODUCE THE REPORTED FAILURE; HOWEVER, HE OBSERVED ERROR CODES 45 (SYSTEM FAILURE) AND 65 (SAFETY VENT FAILURE) AS WELL AS "IABP SHUTDOWN" IN THE SYSTEM FAULT LOGS. HE REPLACED THE DRIVE MANIFOLD (PART NUMBER: 0104-00-0018). THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHILE THEY WERE PREPARING TO USE THE IABP ON A PT, THE IABP GENERATED A "SYSTEM FAILURE" ALARM. ANOTHER IABP WAS OBTAINED, AND THERAPY WAS INITIATED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 128699 | CS100 | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP. | CS100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |