MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-03 for EDI CATHETER ENFIT 6883898 manufactured by Maquet Critical Care Ab.
[143977924]
(b)(4). Getinge usa sales, llc- (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[143977925]
It was reported that a 24 week +2 premature patient was extubated and was set to be ventilated in the niv nava (non invasive ventilation neurally adjusted ventilatory assist) mode of ventilation. The enfit edi catheter was inserted into the patient and the edi signal was monitored and the enfit edi catheter was left in place. However the patient became unstable and woke up. The patient suffered from bad acidosis. The stomach was full of air and the patient was all pink. The breathing was very difficult. The stomach could not be emptied. An x-ray image was taken and it showed that enfit edi catheter was in the wrong place behind the stomach. The stomach was therefore pressing the lungs and the diaphragm thus making breathing difficult. The enfit edi catheter was removed and the patient was re-intubated. After reintubation the insertion of a small ng-tube was unsuccessful but later a larger ng tube was successfully inserted. Intravenous antibiotic treatment was started. The patient? S intensive care treatment continued for 1? Days and the patient died. Manufacturer reference#: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010042-2019-00305 |
| MDR Report Key | 8578192 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-03 |
| Date of Report | 2019-09-12 |
| Date of Event | 2019-04-11 |
| Date Mfgr Received | 2019-04-12 |
| Date Added to Maude | 2019-05-03 |
| 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 Street | MAQUET CRITICAL CARE AB R |
| Manufacturer City | SOLNA |
| Manufacturer Country | SW |
| Manufacturer G1 | MAGNUS LINDQVIST |
| Manufacturer Street | MAQUET CRITICAL CARE AB R |
| Manufacturer City | SOLNA |
| Manufacturer Country | SW |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EDI CATHETER ENFIT |
| Generic Name | GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS |
| Product Code | PIF |
| Date Received | 2019-05-03 |
| Catalog Number | 6883898 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CRITICAL CARE AB |
| Manufacturer Address | ROENTGENVAGEN 2 SOLNA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-05-03 |