FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX
MDR report key: 2041332
·
Received March 9, 2011
Report
- Report Number
- 1218950-2011-00619
- Event Type
- Malfunction
- Date Received
- March 9, 2011
- Report Date
- February 9, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THEY WERE UNSURE IF A SHOCK WAS DELIVERED DURING AN EXPERIMENTAL PROCEDURE ON A MALE PIG. THE MALE PIG EXPIRED, BUT THE CUSTOMER STATED THAT THIS WAS DUE TO OTHER FACTORS INVOLVED IN THE EXPERIMENTAL PROCEDURES ON THE ANIMAL, AND NOT TO THE REPORTED DEVICE BEHAVIOR. THIS IS NOT REPORTED AS A DEATH BECAUSE THE SUBJECT WAS AN ANIMAL, NOT A PERSON. THIS COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THEY WERE UNSURE IF A SHOCK WAS DELIVERED DURING AN EXPERIMENTAL PROCEDURE ON A MALE PIG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART MRX | MKJ | PHILIPS HEALTHCARE | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |