FDA Adverse Event
Malfunction
Summary report: N
X SERIES
MDR report key: 7565201
·
Received June 4, 2018
Report
- Report Number
- 1220908-2018-01527
- Event Type
- Malfunction
- Date Received
- June 4, 2018
- Report Date
- May 14, 2018
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- UDI-DI
- 00847946012717
- PMA / PMN Number
- K112432/P160
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CREATED IN ERROR ET (B)(4) 2018.
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED AT ZOLL MEDICAL CORPORATION FOR EVALUATION. THE REPORTED PROBLEM WAS VERIFIED AND ATTRIBUTED TO A FAULTY TRANSFORMER ON THE PROCESSOR/BRIDGE/PACE BOARD. THE PROCESSOR/BRIDGE/PACE BOARD WAS REPLACED TO REMEDY THE PROBLEM. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.
Description of Event or Problem · 1
CREATED IN ERROR ET (B)(4) 2018.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED SELF TEST FOR DEFIB FUNCTION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 407236 | X SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | X SERIES | NA | 00847946012717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |