FDA Adverse Event
Malfunction
Summary report: N
CS100
MDR report key: 4047040
·
Received August 26, 2014
Report
- Report Number
- 2249723-2014-01253
- Event Type
- Malfunction
- Date Received
- August 26, 2014
- Date of Event
- February 16, 2013
- Report Date
- February 18, 2013
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- PMA / PMN Number
- K031636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REPRESENTATIVE REPLACED ALL CONTAMINATED PARTS - CONDENSATE REMOVAL, MODULE (P/N 0997-00-0986-01), SAFETY DISC (P/N 0997-00-0985-01), PURGE ASSEMBLY (P/N 0104-00-0026), BLOOD DETECT TUBING (P/N 0008-00-0312), MALE LUER FITTING (0103-00-0398-01), CLEAR TUBING (P/N 0008-08-0001). CHECKED BLOOD DETECT CIRCUIT, CALIBRATION, OPERATIONAL. THE IABP SAFETY TESTED TO FACTORY SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THE IABP GENERATED A "RAPID GAS LOSS" ALARM, AND A "BLOOD DETECTED" ALARM. THE PATIENT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 518048 | CS100 | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP. | CS100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |