MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-01 for PAGEWRITER TOUCH CARDIOGRAPH 860315 manufactured by Philips Medical Systems.
[140606573]
A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[140606574]
The customer reported that the unit was freezing up and the screen went black while the device was connected to a patient in the emergency department and they lost the study.
Patient Sequence No: 1, Text Type: D, B5
[147901901]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2019-02486 |
| MDR Report Key | 8471081 |
| Date Received | 2019-04-01 |
| Date of Report | 2019-03-20 |
| Date Mfgr Received | 2019-03-20 |
| Device Manufacturer Date | 2014-09-03 |
| Date Added to Maude | 2019-04-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERT CORNING |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PAGEWRITER TOUCH CARDIOGRAPH |
| Generic Name | PAGEWRITER TC70 CARDIOGRAPH |
| Product Code | DPS |
| Date Received | 2019-04-01 |
| Model Number | 860315 |
| Catalog Number | 860315 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-01 |