N
Patient 1
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
MAUDE MDR 6415991
- MDR report key
- 6415991
- Report number
- 1220908-2017-00539
- Event key
- 0
- Event type
- 3
- Date received
- 2017-03-18
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Address
- 269 MILL ROAD CHELMSFORD MA 01824 US
- Phone
- 978-978-9784
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ASSY,MAIH, 2.7 DIA, W/SWITCH, 100-120V ONLY | INTERNAL PADDLE | ZOLL MEDICAL CORPORATION | LLD | 1011-0139-03 | 8011-0139-03 | NA | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-03-18 | 0 |
Event Narratives#
D
Patient 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE ASSOCIATED DEVICE FAILED TO DISCHARGE USING THESE INTERNAL HANDLES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
N
Patient 1
THIS FOLLOW UP MEDWATCH REPORT IS REPORTING THE EVALUATION OF THE DEVICE. THIS FOLLOW UP MEDWATCH REPORT IS ALSO UPDATING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. EVALUATION RESULTS: THE REPORTED MALFUNCTION WAS OBSERVED AND ATTRIBUTED TO AN OPEN BETWEEN PIN 2 AND PIN 4; WHICH IS DIRECTLY RELATED TO THE DISCHARGE SWITCH WITHIN THE INTERNAL HANDLES. THE INTERNAL HANDLES WERE SCRAPPED. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.