FDA Adverse Event
Malfunction
Summary report: N
AUTOCAT2 WAVE
MDR report key: 2052030
·
Received March 2, 2011
Report
- Report Number
- 1219856-2011-00088
- Event Type
- Malfunction
- Date Received
- March 2, 2011
- Date of Event
- February 22, 2011
- Report Date
- March 1, 2011
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DSP
- PMA / PMN Number
- K060309
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE WILL NOT BE RETURNED FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED PER FIELD SVC REPORT: SYMPTOM - INTERMITTENT LOSS VIDEO DISPLAY. UNIT WOULD CONTINUE TO PUMP. FINDINGS/ACTION TAKEN: BIOMED STATED THAT THIS HAS BEEN AN ONGOING PROBLEM. THEY HAVE CHECKED THIS PUMP OUT SEVERAL TIMES AND HAVE NOT BEEN ABLE TO DUPLICATE THE PROBLEM UNTIL RECENTLY. AFTER RUNNING THE PUMP FOR 3 DAYS, THE DISPLAY HAD ONLY VERTICAL LINES ON IT. PARTS WERE SENT TO AND REPLACED BY HOSPITAL BIOMED. ADDITIONAL INFO RECEIVED ON (B)(6) 2011 BY THE BIOMED TECH STATED THAT THE PUMP WAS EXCHANGED OFF THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOCAT2 WAVE | INTRA-AORTIC BALLOON PUMP PRODUCTS | DSP | ARROW INTL., INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |