MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-21 for INTELLISPACE CC & ANESTHESIA 866072 manufactured by Philips Medical Systems.
[36633253]
A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[36633254]
It was reported that the epidurmal order didn't display update after flow rate change from 8ml/h to 3ml/h. The error was noticed by the attending physician who discontinued the incorrect order that was displayed. The correct order was then administered to the patient.
Patient Sequence No: 1, Text Type: D, B5
[43609693]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2016-00475 |
| MDR Report Key | 5383569 |
| Date Received | 2016-01-21 |
| Date of Report | 2016-01-13 |
| Date Mfgr Received | 2016-01-13 |
| Date Added to Maude | 2016-01-21 |
| 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 | MRS. WENDY CHADBOURNE |
| 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 CC & ANESTHESIA |
| Generic Name | INTELLISPACE CC & ANESTHESIA |
| Product Code | DXJ |
| Date Received | 2016-01-21 |
| Model Number | 866072 |
| 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 | 2016-01-21 |