D
Patient 1
IN 2008, THE CUSTOMER REPORTED THAT THE ECG DATA THAT WAS TRANSMITTED TO THE HOLTER APPLICATION DID NOT MATCH WHAT WAS BEING DISPLAYED BY THE PATIENT MONITORING PIC (IIC) PHILIPS INFORMATION SYSTEM.
MAUDE MDR 1489015
- MDR report key
- 1489015
- Report number
- 1218950-2009-01229
- Event key
- 0
- Event type
- 3
- Date received
- 2009-09-25
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- 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 | ZYMED HOLTER SOFTWARE | PHILIPS MEDICAL SYSTEMS | MLO | 860292 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-09-25 | 0 |
Event Narratives#
N
Patient 1
IN 2008, THE CUSTOMER REPORTED THAT THE ECG DATA THAT WAS TRANSMITTED TO THE HOLTER APPLICATION DID NOT MATCH WHAT WAS BEING DISPLAYED BY THE PATIENT MONITORING PIC (IIC) PHILIPS INFORMATION SYSTEM. IN DECEMBER OF 2008, PHILIPS EVALUATED DATA PROVIDED BY THE CUSTOMER AND DETERMINED THAT THERE WAS A MALFUNCTION, WHERE THE TIME STAMPS ON THE EXPORTED HOLTER ECG FILE DID NOT MATCH THE SCREEN CAPTURE OF THE PIC (IIC) PROVIDED BY THE CUSTOMER. THE DATA DID NOT APPEAR TO BE MISSING OR ALTERED IN ANY OTHER WAY. NOTE THAT NO DEVICE WAS RETURNED TO PHILIPS, BUT SAMPLE ECG FILED WERE RETURNED TO PHILIPS FOR EVALUATION.