FDA Adverse Event
Malfunction
Summary report: N
PACEART SYSTEM
MDR report key: 2131052
·
Received June 16, 2011
Report
- Report Number
- 2182208-2011-00892
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- April 21, 2011
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DPS
- PMA / PMN Number
- K024278
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PACEART SYSTEM DISPLAYED AN ERROR AND "LOCKED UP" WHEN A CLINICIAN WAS TRYING TO ACCESS A PATIENT RECORD. THE CLINICIAN WAS INSTRUCTED ON HOW TO END THE TASK AND WAS ABLE TO CONTINUE WORKING WITH NO FURTHER ERRORS. THE PRODUCT REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PACEART SYSTEM | SOFTWARE | DPS | MEDTRONIC, INC. | GCII | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |