MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-06 for INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 866148 manufactured by Philips Medical Systems.
[135503559]
A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[135503560]
Antibiotic cefotaxime did not show in the icca worklist resulting in a delay in an administration. The customer has stated the medication was prescribed in the usual way but it did not generate scheduling and then did not appear in the work list and the patient did not receive antibiotics. After copying and updating the frequency, the order then appeared. There was no report of any adverse patient affect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-2019-01051 |
| MDR Report Key | 8311228 |
| Date Received | 2019-02-06 |
| Date of Report | 2019-01-31 |
| Date Mfgr Received | 2019-01-31 |
| Device Manufacturer Date | 2012-04-16 |
| Date Added to Maude | 2019-02-06 |
| 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 | 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 | INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 |
| Generic Name | CLINICAL INFORMATION MANAGEMENT SYSTEM |
| Product Code | DXJ |
| Date Received | 2019-02-06 |
| 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 | 1. Other | 2019-02-06 |