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 2019-04-12 for INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 866148 manufactured by Philips Medical Systems.
[141816937]
A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[141816938]
The customer reported the were unable to retrieve patient record in intellispace critical care and anesthesia (icca). Patient death was reported by the customer. The initial information does not indicate whether the device was a factor.
Patient Sequence No: 1, Text Type: D, B5
[144793544]
Additional information was received from a field service engineer (fse) that the end user used the search function in icca to review patient history, however they could not find any record including admitted record in icca related to the patient. The fse stated the customer was attempting to review the patient? S history which included electrocardiogram (ecg) data and icca record (demographic data). Further information was received from the customer that the patient? S id was changed following a his (hospital information system) update on customer? S system and that the alleged issue was related to a customer workflow issue and not a configuration issue. The customer clarified that the alleged issue did not contribute to patient? S death. The customer stated there was no malfunction with the phillips product. The fse had provided customer with information. Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2019-02802 |
| MDR Report Key | 8510876 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-08 |
| Date of Event | 2019-04-07 |
| Date Mfgr Received | 2019-04-08 |
| Device Manufacturer Date | 2016-02-19 |
| Date Added to Maude | 2019-04-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2019-04-12 |
| Model Number | 866148 |
| 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 | 2019-04-12 |