FDA Adverse Event
Injury
Summary report: N
HEART START XL
MDR report key: 3115590
·
Received May 13, 2013
Report
- Report Number
- 1218950-2013-01725
- Event Type
- Injury
- Date Received
- May 13, 2013
- Report Date
- May 7, 2013
- Manufacturer
- AGILENT TECHNOLOGIES, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A FAILURE TO DISCHARGE DURING A CARDIOVERSION. THIS WAS ENTERED AS A SERIOUS INJURY BUT THERE IS NO INFORMATION AVAILABLE YET AS TO WHAT IMPACT THIS FAILURE TO DISCHARGE DURING CARDIOVERSION HAD ON THE INVOLVED PATIENT. WE ARE REQUESTING ADDITIONAL INFORMATION AND THIS INVESTIGATION REMAINS OPEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210530 | HEART START XL | MKJ | AGILENT TECHNOLOGIES, INC. | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |