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 2017-02-21 for INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 866148 manufactured by Philips Medical Systems.
[67888276]
A follow up report will be submitted after philips obtains more information concerning this event.
Patient Sequence No: 1, Text Type: N, H10
[67888277]
The customer reported that an insulin order could not be discontinued and a patient received an extra dosage. The customer has alleged a serious injury.
Patient Sequence No: 1, Text Type: D, B5
[79063173]
The philips solution center ( psc) contacted the customer and was unable to gather any reports of an icca patient receiving an extra dose of any medication. The customer has alleged a serious injury but there were no documented reports for this particular patient 's case. The inability to edit an order has been previously reported from other sites, however there was not enough information provided by the customer to determine root cause. In addition the customer did not request a philips field service engineer to visit the site and conduct a thorough investigation into root cause. This issue could be reproduced by the customer. There have been no reported deaths or serious injuries related to this issue. The cause is unknown due to insufficient information. The latest feedback from this customer was this was a onetime event or it was a user error. This case has been determined as a "cause unknown" due to insufficient information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2017-01201 |
| MDR Report Key | 6347245 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-21 |
| Date of Report | 2017-02-15 |
| Date of Event | 2017-02-15 |
| Date Mfgr Received | 2017-02-15 |
| Date Added to Maude | 2017-02-21 |
| 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 | MS. DENYSE MURPHY |
| 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 CRITICAL CARE & ANESTHESIA REV G.0 |
| Generic Name | CLINICAL INFORMATION MANAGEMENT SYSTEM |
| Product Code | DXJ |
| Date Received | 2017-02-21 |
| Model Number | 866148 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-02-21 |