MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-10-14 for INTELLISPACE CC & ANESTHESIA 866072 manufactured by Philips Medical Systems.
[57428757]
A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[57428758]
The customer reported a patient death occurred due to the administration time of a drug not appearing in the icca worklist. The patient was described to have been in septic shock and expired.
Patient Sequence No: 1, Text Type: D, B5
[66238608]
No malfunction of the device was detected. This was a clinical workflow error. There was no frequency entered for the order by the clinical staff. In addition, the clinical staff failed to notice an icon (clock icon with a question mark ) that indicates that the order is missing a schedule and needs to be completed. The nurse was only using the worklist. Icca has a red warning message that states not to use the worklist exclusively. The administration record should always be used. The schedule wasn? T created for an antifungal drug order because there wasn? T a frequency entered by the clinical staff. A schedule cannot be created without a frequency entered. A philips clinical specialist explained the correct workflow to the end user and also communicated to not rely explicitly on the work list and recommended to always check in the mar for completed orders as documented in the clinicians toolkit manual. The device remains at the customer site, and there have been no subsequent calls logged for this device/issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2016-06473 |
| MDR Report Key | 6029656 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-10-14 |
| Date of Report | 2016-10-11 |
| Date of Event | 2016-09-06 |
| Date Mfgr Received | 2016-10-11 |
| Date Added to Maude | 2016-10-14 |
| 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 | 9723897516 |
| 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 | 2016-10-14 |
| 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. Death; 2. Life Threatening; 3. Other | 2016-10-14 |