D
Patient 1
THE CUSTOMER REPORTED THAT ONE HOLTER SCAN OVER-WROTE INTO ANOTHER SCAN, WHICH CAUSED TWO PTS TO HAVE THE SAME ECG DATA.
MAUDE MDR 1489036
- MDR report key
- 1489036
- Report number
- 1218950-2009-01056
- Event key
- 0
- Event type
- 3
- Date received
- 2009-08-19
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 999
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- PATTI NILL
- Address
- 3000 MINUTEMAN RD. ANDOVER MA 01810 US
- Phone
- 978-978-9786
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 1810 HOLTER ANALYSIS SW | PHILIPS MEDICAL SYSTEMS | MLO | M3730A | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-08-19 | 0 |
Event Narratives#
N
Patient 1
THE CUSTOMER REPORTED THAT ONE HOLTER SCAN OVER-WROTE INTO ANOTHER SCAN, WHICH CAUSED TWO PTS TO HAVE THE SAME ECG DATA. THE FACTORY HAS NOT YET RECEIVED THE DEVICE FOR EVAL, AND THE COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED, UPON COMPLETION OF THE INVESTIGATION.