FDA Adverse Event
Malfunction
Summary report: N
CS100
MDR report key: 3902593
·
Received May 9, 2014
Report
- Report Number
- 2249723-2014-00567
- Event Type
- Malfunction
- Date Received
- May 9, 2014
- Date of Event
- February 17, 2013
- Report Date
- February 19, 2013
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- PMA / PMN Number
- K031636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REP REBUILT THE COMPRESSOR USING THE 5000 HOUR PREVENTIVE MAINTENANCE KIT (PART NUMBER 0040-00-0147). THE IABP WAS TESTED TO FACTORY SPEC. IT FUNCTIONAL NORMALLY AND WAS RETURNED TO THE CUSTOMER. REFERENCE: (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PT, THE IABP GENERATED AN "AUTO FILL FAILURE" ALARM AND WENT IN STANDBY FOR 17 MINUTES. THE IABP WAS REBOOTED AND WORKED FOR ONE MORE HOUR THAN THE IABP GENERATED THE SAME "AUTO FILL FAILURE" ALARM AND STOPPED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282293 | CS100 | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP. | CS100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |