FDA Adverse Event
Malfunction
Summary report: N
SENSORMEDICS
MDR report key: 907188
·
Received March 15, 2007
Report
- Report Number
- 2021710-2007-00013
- Event Type
- Malfunction
- Date Received
- March 15, 2007
- Date of Event
- February 14, 2007
- Report Date
- March 15, 2007
- Manufacturer
- VIASYS RESPIRATORY CARE INC
- Product Code
- BZG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE BY THE USER FACILITY WAS DOCUMENTED BY A VIASYS FIELD SERVICE REP. IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. "UNIT ONLY SHOCKS BY ELECTROSTATIC. BHIOMED PERFORMED ELECTRICAL SAFETY, NO PROBLEM FOUND."
Description of Event or Problem · 1
THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A VIASYS TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. "CUSTOMER STATES THAT THEY ARE ALWAYS GETTING SHOCKED WHEN THEY ARE USING THE SYSTEM. REPLACED EVER SINCE GETTING SHOCKED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SENSORMEDICS | PULMONARY/METABOLIC SYSTEMS | BZG | VIASYS RESPIRATORY CARE INC | VMAX ENCORE 29 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |