FDA Adverse Event
Malfunction
Summary report: N
LEFEVEST WCD 4000 SYSTEM
MDR report key: 2885292
·
Received November 21, 2012
Report
- Report Number
- 3008642652-2012-03059
- Event Type
- Malfunction
- Date Received
- November 21, 2012
- Date of Event
- October 22, 2012
- Report Date
- November 16, 2012
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION SUMMARY: SERVICE INVESTIGATION OF E-BELT SN (B)(4) HAS BEEN COMPLETED. UPON SERVICE INVESTIGATION THE ELECTRODE BELT FAILED A FALL-OFF TEST. UPON INVESTIGATION THE DISTRIBUTION NODE PCA WAS NOT SENDING VOLTAGES OUT TO THE ECGS. THE CAUSE WAS LIKELY RELATED TO U725 AND U723. THE ROOT CAUSE OF THE DEFECTIVE DN PCA COMPONENTS WAS UNABLE TO BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE COMPONENTS ON THE DN PCA. THE LAST PATIENT TO USE THIS DEVICE DID NOT REPORT ANY DEFICIENCIES.
Description of Event or Problem · 1
A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. UPON SERVICE INVESTIGATION OF ELECTRODE BELT SN (B)(4), THE BELT FAILED A FALL-OFF TEST. THE LAST PATIENT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY DEFICIENCIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |