FDA Adverse Event
Malfunction
Summary report: N
DASH 4000
MDR report key: 933914
·
Received October 26, 2007
Report
- Report Number
- 2124823-2007-00063
- Event Type
- Malfunction
- Date Received
- October 26, 2007
- Date of Event
- September 19, 2007
- Report Date
- October 26, 2007
- Manufacturer
- GE HEALTHCARE
- Product Code
- DRT
- PMA / PMN Number
- K051367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
THE CUSTOMER ALLEGES, THE DASH MONITOR MISSED A V-TACH ALARM THAT CAUSED A DELAY IN RECOGNITION AND/OR TREATMENT OF A SIGNIFICANT CARDIAC EVENT. THE PATIENT WAS IN VENTRICULAR-TACHYCARDIA THAT RESULTED IN HLR. DEFIBRILLATION WAS NEEDED TO GET THE PATIENT BACK IN SINUS RHYTHM. NO PATIENT DEATH OR INJURY WAS REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DASH 4000 | PATIENT MONITOR | DRT | GE HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |