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 2018-08-31 for INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 866148 manufactured by Philips Medical Systems.
[118901923]
A follow up report will be submitted once the investigation is complete. Patient information has been requested. Serial number is unknown at time of report.
Patient Sequence No: 1, Text Type: N, H10
[118901924]
The customer has alleged a drug "overdose" event occurred due to a user drug order configuration that resulted in a overdose of paracetamol iv where a 3. 5 kg patient was prescribed 45 mg of paracetamol iv and the max should be 10 mg/kg iv for this patient. The drug was given. While it was described that the patient was not harmed, based on the patient being an infant and the inappropriate dosing, conservatively philips will classify this event as a serious injury based upon the limited initial information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-2018-07055 |
| MDR Report Key | 7837275 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-31 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-08-28 |
| Date Mfgr Received | 2018-08-29 |
| Date Added to Maude | 2018-08-31 |
| 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 CRITICAL CARE & ANESTHESIA REV G.0 |
| Generic Name | CLINICAL INFORMATION MANAGEMENT SYSTEM |
| Product Code | DXJ |
| Date Received | 2018-08-31 |
| Model Number | 866148 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-08-31 |