FDA Adverse Event
Malfunction
Summary report: N
HEARTSINE SAMARITAN 300P PAD PAK
MDR report key: 6463477
·
Received April 6, 2017
Report
- Report Number
- 3004123209-2017-00291
- Event Type
- Malfunction
- Date Received
- April 6, 2017
- Date of Event
- March 10, 2017
- Report Date
- May 4, 2017
- Manufacturer
- HEARTSINE TECHNOLOGIES LTD
- Product Code
- MKJ
- PMA / PMN Number
- K041067
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 0
EXEMPTION NUMBER E2015058 HEARTSINE TECHNOLOGIES LTD ( MANUFACTURER ) IS SUBMITTING THE REPORT ON TECHNOLOGIES LLC ( IMPORTER BEHALF OF HEARTSINE) H3 OTHER TEXT : NOT YET RETURNED TO MANUFACTURER
Additional Manufacturer Narrative · 0
EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD ( MANUFACTRER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER) THE INVESTIGATION WAS UNABLE TO REPLICATE THE REPORTED FAULT. MEMEORY FULL WARNING MAY BE DUE TO REGULAR POWER CYCLING.
Description of Event or Problem · 0
THERE WAS NO PATIENT INVOLVED IN THIS EVENT. MEMORY FULL PROMPT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250899 | HEARTSINE SAMARITAN 300P PAD PAK | AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | HEARTSINE TECHNOLOGIES LTD | SAM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |