FDA Adverse Event
Malfunction
Summary report: N
HEARTSINE SAMARITAN 300P AND PAD PAK
MDR report key: 2915240
·
Received December 19, 2012
Report
- Report Number
- 3004123209-2012-00856
- Event Type
- Malfunction
- Date Received
- December 19, 2012
- Date of Event
- November 28, 2010
- Report Date
- December 17, 2012
- Manufacturer
- HEARTSINE TECHNOLOGIES LTD
- Product Code
- MKJ
- PMA / PMN Number
- K052465
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PAD DEVICE WAS INSTALLED ON (B)(6) 2010, AND OPERATED SUCCESSFULLY UNTIL A FAILED SELF-TEST ON (B)(6) 2010, FOR A LOW BATTERY. ON INSPECTION OF THE PAD DEVICE AN INCONSISTENT VOLTAGE MEASUREMENT WAS FOUND WHICH WOULD INDICATE A FAULT WITH THE POGO-PINS. THE PAD PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELLED FOR SINGLE USE, BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE, WHICH IS WHY THE ¿UNKNOWN¿ BOX HAS BEEN CHECKED IN THIS REPORT.
Description of Event or Problem · 1
THERE WAS NO PT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE THE DEVICE WAS EMITTING A LOW BATTERY WARNING. A DEVICE IN THIS FAULT MODE, IF LEFT UNDETECTED COULD RESULT IN THE FAILURE OF THE DEVICE TO PERFORM AS INTENDED IF REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSINE SAMARITAN 300P AND PAD PAK | AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | HEARTSINE TECHNOLOGIES LTD | PAD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |