FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 98
MDR report key: 2862153
·
Received November 29, 2012
Report
- Report Number
- 2249723-2012-00427
- Event Type
- Malfunction
- Date Received
- November 29, 2012
- Date of Event
- October 7, 2012
- Report Date
- October 7, 2012
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A COMPANY SERVICE REPRESENTATIVE WAS UNABLE TO REPRODUCE THE REPORTED PROBLEM. HE RECOMMENDED THAT THE CUSTOMER HAVE THE POWER SUPPLY REPLACED AS A PRECAUTIONARY MEASURE; HOWEVER, BASED UPON THE COST OF THE REPAIR AND THE AGE OF THE DEVICE (12 YEARS), THE CUSTOMER HAS ELECTED NOT TO PROCEED WITH THE REPAIR AT THIS TIME, AND HAS INDICATED THAT THEY MAY DISCARD THE IABP.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THE IABP SHUT DOWN AND COULD NOT BE TURNED ON AGAIN. 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 |
|---|---|---|---|---|---|---|---|
| 1 | SYSTEM 98 | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP. | SYSTEM 98 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |