FDA Adverse Event
Malfunction
Summary report: N
CS300
MDR report key: 4115032
·
Received September 15, 2014
Report
- Report Number
- 2249723-2014-01342
- Event Type
- Malfunction
- Date Received
- September 15, 2014
- Date of Event
- June 28, 2013
- Report Date
- June 28, 2013
- Manufacturer
- DATASCOPE CORP
- Product Code
- DSP
- PMA / PMN Number
- K063525
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REP OBSERVED THAT THE VACUUM WAS LOW AT THE PUMP AND THE SAFETY DISK WAS EXPIRED. THE COMPANY REP REPLACED THE SAFETY DISK (PART NUMBER 0997-00-0985) AND INSTALLED THE 5000 HOUR PREVENTATIVE MAINTENANCE KIT (PART NUMBER: 0040-00-0147). 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 THE IABP WAS IN USE ON A PATIENT, THE IABP GENERATED AN "AUTO FILL FAILURE" 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 |
|---|---|---|---|---|---|---|---|
| 569569 | CS300 | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP | CS300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |