FDA Adverse Event
Malfunction
Summary report: N
HORIZON CARDIOLOGY
MDR report key: 1713905
·
Received June 2, 2010
Report
- Report Number
- 1713905
- Event Type
- Malfunction
- Date Received
- June 2, 2010
- Date of Event
- March 22, 2010
- Report Date
- June 2, 2010
- Manufacturer
- MCKESSON INFORMATION SOLUTIONS LLC, MCKESSON ISRAEL LTD
- Product Code
- DQK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
Narratives
Description of Event or Problem · 1
PATIENT WAS BROUGHT TO CATH LAB FOR EMERGENT TEMPORARY PACEMAKER. MONITOR TECH INITIATED THE HORIZON CARDIOLOGY PROGRAM FOR MONITORING THE PATIENT AND DOCUMENTING THE CASE. SYSTEM FAILED TO INITIALIZE. AN ERROR MESSAGE APPEARED "INTERNAL". IS WAS CONTACTED, BUT THEY WERE UNABLE TO RESOLVE ISSUE. MCKESSON SUPPORT WAS ALSO CONTACTED FOR ASSISTANCE. SITUATION NOT RESOLVED UNTIL CASE COMPLETED. ALL DOCUMENTATION AND VITAL SIGNS DONE MANUALLY. NO HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HORIZON CARDIOLOGY | HEMODYNAMIC MONITOR SYSTEM | DQK | MCKESSON INFORMATION SOLUTIONS LLC, MCKESSON ISRAEL LTD | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |