FDA Adverse Event
Malfunction
Summary report: N
CARELINK PROGRAM W/TELEMETRY C
MDR report key: 2131796
·
Received June 16, 2011
Report
- Report Number
- 2182208-2011-01026
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- April 28, 2011
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DXY
- PMA / PMN Number
- P890003/S080
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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. EVALUATION SUMMARY: (B)(4) ANALYSIS CONFIRMED THE OVERLAY SCREEN, THE KEYBOARD HINGES, AND THE POWER CORD BAY WERE BROKEN. THE DISPLAY SCREEN ALSO HAD TWO BROKEN LATCHES, THE MEDIA BAY DOOR LATCH WAS BROKEN OUT AND MISSING, THE LOWER CASE WAS DAMAGED, AND THE KEYBOARD SLIDE PLATE WAS MISSING.
Description of Event or Problem · 1
IT WAS REPORTED THE PROGRAMMER HAS A CRACKED SCREEN, AND THE BACK DOOR AND KEYBOARD DOOR ARE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARELINK PROGRAM W/TELEMETRY C | PROGRAMMER | DXY | MEDTRONIC, INC. | 2090W | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |