FDA Adverse Event
Injury
Summary report: N
R SERIES DEFIBRILLATOR
MDR report key: 4909784
·
Received July 7, 2015
Report
- Report Number
- 1220908-2015-01700
- Event Type
- Injury
- Date Received
- July 7, 2015
- Report Date
- June 18, 2015
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K060559
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS REC'D THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Additional Manufacturer Narrative · 1
THE REPORTED MALFUNCTION WAS OBSERVED AND ATTRIBUTED TO A SYSTEM INTERCONNECTION FLEX CABLE THAT WAS NOT PROPERLY SEATED. THE CABLE WAS REPLACED TO CORRECT THE REPORTED PROBLEM. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNK), THE DEVICE DID NOT RESPOND TO THE FRONT PANEL CONTROLS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 437639 | R SERIES DEFIBRILLATOR | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | R SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |