FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART XL
MDR report key: 2511403
·
Received March 15, 2012
Report
- Report Number
- 1218950-2012-00937
- Event Type
- Malfunction
- Date Received
- March 15, 2012
- Report Date
- February 20, 2012
- Manufacturer
- AGILENT TECHNOLOGIES, INC
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THE BATTERY LED CHARGE INDICATOR LIGHT IS ALWAYS AMBER AND IT NEVER CHANGES TO GREEN TO INDICATE A CHARGE. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE BATTERY LED CHARGE INDICATOR LIGHT IS ALWAYS AMBER AND IT NEVER CHANGES TO GREEN TO INDICATE A CHARGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART XL | MKJ | AGILENT TECHNOLOGIES, INC | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |