MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-20 for PAGEWRITER TOUCH CARDIOGRAPH 860315 manufactured by Philips Medical Systems.
[100560593]
A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[100560594]
The customer reported audio failed on their tc70 device. It was confirmed that the device had no sound and failed audio test. There was no patient injury/harm reported.
Patient Sequence No: 1, Text Type: D, B5
[106569526]
Patient Sequence No: 1, Text Type: N, H10
[106569527]
The customer reported audio failed on their tc70 device. It was confirmed that the device had no sound and failed audio test. The device was not in clinical use at the time of the event. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-2018-01965 |
| MDR Report Key | 7283549 |
| Date Received | 2018-02-20 |
| Date of Report | 2018-01-25 |
| Date Mfgr Received | 2018-01-25 |
| Device Manufacturer Date | 2012-11-30 |
| Date Added to Maude | 2018-02-20 |
| 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 |
| 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 | 2018-02-20 |
| Model Number | 860315 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-02-20 |