FDA Adverse Event
Injury
Summary report: N
KAAT II+:E/FE W/REC & HEL 115V
MDR report key: 747058
·
Received August 9, 2006
Report
- Report Number
- 1219856-2006-00269
- Event Type
- Injury
- Date Received
- August 9, 2006
- Date of Event
- July 17, 2006
- Report Date
- August 9, 2006
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS NOT AVAILABLE FOR EVAL. NO FURTHER EVAL POSSIBLE. ROOT CAUSE UNK.
Description of Event or Problem · 1
IT WAS REPORTED TO ARROW CLINICAL SUPPORT (ACS) THAT CLINICIAN WAS HAVING SYSTEM ERROR 3 ALARMS. ACS ADVISED THAT BELLOWS MAY BE CAUSE OF ALARMS. CLINICAIN AGREED. PUMP WAS EXCHANGED AND AN ACAT 1 PLUS. THERE WERE NO REPORTED PT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KAAT II+:E/FE W/REC & HEL 115V | INTRA-AORTIC BALLOON PUMP PRODUCTS | DSP | ARROW INTL., INC. | NA | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |