MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-05 for INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 866148 manufactured by Philips Medical Systems.
[44588046]
A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[44588047]
It was reported that a potential safety issue where a heart transplant patient may not have have received treatment due to drug tacrolimus (prograf missing in the icca worklist. No patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
[50210050]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2016-02692 |
| MDR Report Key | 5634611 |
| Date Received | 2016-05-05 |
| Date of Report | 2016-04-21 |
| Date Mfgr Received | 2016-04-21 |
| Device Manufacturer Date | 2014-07-08 |
| Date Added to Maude | 2016-05-05 |
| 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 |
| 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 |
| 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 | 2016-05-05 |
| Model Number | 866148 |
| Lot Number | N/A |
| 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 | 2016-05-05 |