MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-06 for PAGEWRITER TC20 CARDIOGRAPH 860332 manufactured by Philips Medical Systems.
[126397283]
A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[126397284]
Customer reported device got unexpectedly burnt. There was no patient injury/harm in association with this event.
Patient Sequence No: 1, Text Type: D, B5
[138759789]
Patient Sequence No: 1, Text Type: N, H10
[138759790]
Customer reported device got unexpectedly burnt. The customer confirmed that the device was not connected to a patient when this event happened. There was no patient injury/harm in association with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-2018-08644 |
| MDR Report Key | 8043562 |
| Date Received | 2018-11-06 |
| Date of Report | 2018-10-29 |
| Date Mfgr Received | 2018-10-29 |
| Device Manufacturer Date | 2015-02-06 |
| Date Added to Maude | 2018-11-06 |
| 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 | MISS RANA ATA |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Manufacturer G1 | PHILIPS HEALTHCARE - ANDOVER |
| Manufacturer Street | 3000 MINUTEMAN RD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PAGEWRITER TC20 CARDIOGRAPH |
| Generic Name | PAGEWRITER TC20 CARDIOGRAPH |
| Product Code | DPS |
| Date Received | 2018-11-06 |
| Model Number | 860332 |
| 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 | 2018-11-06 |