FDA Adverse Event
Malfunction
Summary report: N
X SERIES
MDR report key: 6937178
·
Received October 10, 2017
Report
- Report Number
- 1220908-2017-02450
- Event Type
- Malfunction
- Date Received
- October 10, 2017
- Report Date
- September 19, 2017
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- DRT
- UDI-DI
- 00847946006327
- PMA / PMN Number
- K112432
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL PROCODE = MKJ. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION AND THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WITHOUT DUPLICATING THE REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE MONITORING A FEMALE PATIENT (AGE UNKNOWN), THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS AND THE DISPLAY BLANKED OUT. 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 |
|---|---|---|---|---|---|---|---|
| 714751 | X SERIES | DEFIBRILLATOR/PACEMAKER | DRT | ZOLL MEDICAL CORPORATION | X SERIES | NA | 00847946006327 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |