MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-17 for INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 866148 manufactured by Philips Medical Systems.
[70422257]
A follow up report will be submitted once the investigation is complete. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[70422258]
The customer has reported a potential safety issue where an unexpected drug order was scheduled in the (b)(4) worklist there was no patient impact reported there were no extra drug dosage administered to the patient.
Patient Sequence No: 1, Text Type: D, B5
[105955724]
The software error will be considered for a fix in a future release of icca revision.
Patient Sequence No: 1, Text Type: N, H10
[105955725]
The customers reports that an unexpected scheduled intervention appeared in the worklist for an erythromycine order which was stopped. There was no serious injury or death reported regarding this software error.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-2017-01724 |
| MDR Report Key | 6412666 |
| Date Received | 2017-03-17 |
| Date of Report | 2017-02-27 |
| Date Mfgr Received | 2017-02-27 |
| Device Manufacturer Date | 2014-07-08 |
| Date Added to Maude | 2017-03-17 |
| 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 |
| 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 | 2017-03-17 |
| 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 | 2017-03-17 |