FDA Adverse Event
Injury
Summary report: N
HEART START XL
MDR report key: 3042018
·
Received April 2, 2013
Report
- Report Number
- 1218950-2013-01175
- Event Type
- Injury
- Date Received
- April 2, 2013
- Report Date
- March 27, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT A PATIENT HAD A "SUPERFICIAL BURN" WHERE THE DEFIBRILLATOR PADS HAD BEEN PLACED DURING PACING. THE CUSTOMER ALSO REPORTED THAT THE DEFIBRILLATOR WAS DELIVERING PACING SPIKES INAPPROPRIATELY, WHICH IS INVESTIGATED IN A SEPARATE COMPLAINT, (REF MDR #1218950-2013-01174). THIS WAS ENTERED AS A SERIOUS INJURY, BUT IT IS NOT KNOWN FOR WHICH ISSUE THE CUSTOMER BELIEVES A SERIOUS INJURY OCCURRED. WE ARE THEREFORE REPORTING BOTH ISSUES AS A SERIOUS INJURY UNTIL THIS IS CLARIFIED. THE COMPLAINT IS STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT A PATIENT HAD A "SUPERFICIAL BURN" WHERE THE DEFIBRILLATOR PADS HAD BEEN PLACED DURING PACING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134373 | HEART START XL | MKJ | PHILIPS MEDICAL SYSTEMS | M4735A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |