FDA Adverse Event
Malfunction
Summary report: N
HEART START XL
MDR report key: 7964976
·
Received October 15, 2018
Report
- Report Number
- 1218950-2018-08079
- Event Type
- Malfunction
- Date Received
- October 15, 2018
- Report Date
- September 19, 2018
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.
Additional Manufacturer Narrative · 1
PER EMAIL CONVERSATION WITH COMPLAINT INVESTIGATOR AND ADDITIONAL INFORMATION GAINED THROUGH DEVICE EVALUATION, PR (B)(4) HAS BEEN CHANGED TO A LEVEL 1 COMPLAINT, AND IS THEREFORE NOT REPORTABLE. MDV (NOT COMPLETED OR EMAILED TO CA CONTACTS) IS BEING CANCELLED. MDR (B)(4) WILL HAVE FOLLOW-UP SENT AND IS BEING CANCELLED. EMAIL ATTACHED. (BG)
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT A REPLACEMENT OF THE BATTERY IS NEEDED. THERE WAS NO REPORTED PATIENT OR USER INVOLVEMENT AND NO ADVERSE PATIENT/USER IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 804625 | HEART START XL | DEFIBRILLATOR | MKJ | PHILIPS MEDICAL SYSTEMS | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |