MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-16 for INTELLIVUE PIICIX manufactured by Philips Medical Systems.
[89411212]
Patient Sequence No: 1, Text Type: N, H10
[89411213]
Telemetry nurse tried to admit patient to their central station to monitor patient's vital but the keyboard did not work- only very few keys could be entered. The device was troubleshot to the point where piicix central station computer for telemetry unit had to be rebooted. Philips had come out couple of times for this issue and installed an application which prevents the keyboard lock up but doesn't seem to be working as intended. Manufacturer response for central station computer, piicix (per site reporter). Dispatched their fco to install an application/software to prevent keyboard lock up. But it does not seem to be working as intended for this computer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6951587 |
| MDR Report Key | 6951587 |
| Date Received | 2017-10-16 |
| Date of Report | 2017-09-15 |
| Date of Event | 2017-07-19 |
| Report Date | 2017-09-13 |
| Date Reported to FDA | 2017-09-13 |
| Date Reported to Mfgr | 2017-09-13 |
| Date Added to Maude | 2017-10-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTELLIVUE |
| Generic Name | MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS) |
| Product Code | MSX |
| Date Received | 2017-10-16 |
| Model Number | PIICIX |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN RD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-16 |