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 2017-09-18 for INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 866148 manufactured by Philips Medical Systems.
[86465048]
Serial # not provided. A follow-up report will be submitted once the investigation is complete. Patient information is unknown at the present time.
Patient Sequence No: 1, Text Type: N, H10
[86465049]
It was reported that a patient suffered a heart attack after orders for lidocaine were administered. The customer concerns are in regards to icca's functionality for short order drug configuration.
Patient Sequence No: 1, Text Type: D, B5
[104752180]
The customer concerns are in regards to icca's functionality for "short order drug configuration". The customer has described that lidocaine toxicity occurred in their report. The philips field and product support engineering were informed of this incident the issue was investigated via change request (cr) 31085. The occurrence was attributed to a user error in drug order configuration. All continuous drug infusions are configured and prescribed using a specific category. But some drugs can be administered as a short (2-4 hour) infusion. The doctor should have prescribed this drug using the medications order function, but instead used the continuous infusion order when this in fact, was not a continuous infusion. Icca does not have an order category for short infusions. The icca system was operating as designed. The doctor didn? T use the medication order and went to drug infusions for a short duration drip order (less than 4 hours), selecting the other infusion regime instead of the medication order which was configured. No malfunction occurred; this was a use related/misuse issue which the customer has now acknowledged upon investigation by the product team. : no malfunction occurred. All continuous drug infusions are configured and prescribed using a specific category. But some drugs can be administered as a short (2-4 hour) infusion. The doctor should have prescribed this drug using the medications order, but instead used the continuous infusion order. Icca does not have an order category for short infusions. The conclusion was that this was a user error and the icca system worked as designed. This issue is consistent with a misuser issue; improper training and/or improper procedures at the hospital. The customer has taken full responsibility for the error. It was a configuration error in that the pharmacist did not approve it before it was used and there wasn? T proper training of the staff on the new use model for the new order. .
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2017-06448 |
| MDR Report Key | 6872350 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-18 |
| Date of Report | 2017-09-13 |
| Date of Event | 2017-09-13 |
| Date Mfgr Received | 2017-09-13 |
| Device Manufacturer Date | 2014-06-12 |
| Date Added to Maude | 2017-09-18 |
| 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 |
| 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 | 2017-09-18 |
| Model Number | 866148 |
| Lot Number | . |
| 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 | 2017-09-18 |