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 2016-11-15 for INTELLISPACE CC & ANESTHESIA 866072 manufactured by Philips Medical Systems.
[59910434]
A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[59910435]
A medication order of heparin was modified by a doctor (end date entered) but the system did not generate a red flag. Clinician didn't see the end date for the order and the patient was administered an extra dose of heparin resulting in patient bleeding.
Patient Sequence No: 1, Text Type: D, B5
[71257100]
Philips applications specialists have indicated that customer did not use the correct procedure to stop an order. Customer should have right click on order, click on stop order (interrompre in (b)(6)) then edit the order and change the end date, then a red flag appears when changes are saved. (philips toolkit guide for icca revision f page 161 - discontinued orders): workflow error -the issue was fully explained to he customer the customer did confirm this was a workflow error and not a philips product malfunction there was no product malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2016-07207 |
| MDR Report Key | 6103181 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2016-11-15 |
| Date of Report | 2016-11-09 |
| Date of Event | 2016-11-09 |
| Date Mfgr Received | 2016-11-09 |
| Date Added to Maude | 2016-11-15 |
| 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 | 3 |
| Brand Name | INTELLISPACE CC & ANESTHESIA |
| Generic Name | INTELLISPACE CC & ANESTHESIA |
| Product Code | DXJ |
| Date Received | 2016-11-15 |
| Model Number | 866072 |
| 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. Required No Informationntervention | 2016-11-15 |