FDA Adverse Event
Malfunction
Summary report: N
HEART START XL
MDR report key: 3173186
·
Received June 5, 2013
Report
- Report Number
- 1218950-2013-02169
- Event Type
- Malfunction
- Date Received
- June 5, 2013
- Report Date
- May 14, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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 THAT THEY HAD AN INCIDENT YESTERDAY. THE UNIT WAS ON BATTERY, WHILE THEY TRIED TO SHOCK A PATIENT, 2 SHOCKS WORKED THEN THE UNIT SAID LOW BATTERY AND IT SWITCHED OFF IMMEDIATELY. THE CUSTOMER PLUGGED THE UNIT INTO MAINS AND ALL WAS OK AGAIN. THERE WAS NO PATIENT INCIDENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249423 | HEART START XL | MKJ | PHILIPS MEDICAL SYSTEMS | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |