MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-03-08 for PAGEWRITER TOUCH CARDIOGRAPH 860315 manufactured by Philips Medical Systems.
[138248770]
A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[138248771]
The customer reported the monitors shut down and there was a loud noise and a flame coming from the power cord when attaching the ekg-device to the wall. The user was holding the handle of the device and got an electric shock to the left hand.
Patient Sequence No: 1, Text Type: D, B5
[139696630]
The user was holding the plug in the wall socket and received a tingling in the fingers, wrist and arm and a slight headache. There was no treatment needed. The injury is not considered serious as no medical intervention was required and there was no permanent impairment. The customer contacted the customer care solution center (ccsc) for trouble shooting. A field service engineer (fse) confirmed that the problem was caused by the wall socket, and is not considered a product malfunction. The fse recommended that the customer replace the network cable, pin module cable and power cord.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2019-01881 |
| MDR Report Key | 8404112 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-03-08 |
| Date of Report | 2019-03-05 |
| Date Mfgr Received | 2019-03-05 |
| Device Manufacturer Date | 2012-08-20 |
| Date Added to Maude | 2019-03-08 |
| 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 | 3 |
| Brand Name | PAGEWRITER TOUCH CARDIOGRAPH |
| Generic Name | PAGEWRITER TC70 CARDIOGRAPH |
| Product Code | DPS |
| Date Received | 2019-03-08 |
| Model Number | 860315 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Brand Name | PAGEWRITER TOUCH CARDIOGRAPH |
| Generic Name | PAGEWRITER TC70 CARDIOGRAPH |
| Product Code | DPS |
| Date Received | 2019-03-08 |
| Model Number | 860315 |
| Catalog Number | 860315 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-03-08 |