FDA Adverse Event
Malfunction
Summary report: N
HEART START XL
MDR report key: 1983713
·
Received February 3, 2011
Report
- Report Number
- 1218950-2011-00302
- Event Type
- Malfunction
- Date Received
- February 3, 2011
- Report Date
- January 9, 2011
- Manufacturer
- AGILENTTECHNOLOGIES, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE HOSPITAL'S BIOMEDICAL ENGINEER REPORTED A FAILURE TO POWER UP. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS EVALUATED BY THE CUSTOMER'S BIOMED, AND IT WAS DETERMINED THAT THE POWER SUPPLY HAD FAILED. A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER TO RESOLVE THE FAILURE.
Description of Event or Problem · 1
THE HOSPITAL'S BIOMEDICAL ENGINEER REPORTED A FAILURE TO POWER UP. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEART START XL | MKJ | AGILENTTECHNOLOGIES, INC. | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |