MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-06 for INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 866148 manufactured by Philips Medical Systems.
[185272577]
A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[185272578]
The customer alleged when a doctor prescribes fentanyl via transdermal route (patch with the following dosage: 100 g/h) in "discontinue order" category, it is not possible to choose a dose in g/h. Thus, the user has to write the dose contained in the patch which is not clear because for example he will write? 16. 8 mg? To translate? 100 g/h during 72 h. No adverse event involving patient or user was reported.
Patient Sequence No: 1, Text Type: D, B5
[185395113]
Clinical application specialist explained how to configure the drug properly to answer the customer request.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2020-01510 |
| MDR Report Key | 9797285 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2016-11-18 |
| Date Added to Maude | 2020-03-06 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. BETTY HARRIS |
| 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 | INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 |
| Generic Name | CLINICAL INFORMATION MANAGEMENT SYSTEM |
| Product Code | DXJ |
| Date Received | 2020-03-06 |
| Model Number | 866148 |
| 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 | 2020-03-06 |