MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-17 for MEDLINE manufactured by Medline Industries.
[80170537]
A 65f taken to operating room for placement of a trach and peg. When the patient was placed on mechanical ventilation, anesthesia could not ventilate her. Multiple efforts were made to ventilate the patient without success. Cpr then was initiated due to loss of pulse. Unfortunately, the patient was unable to be revived. Upon subsequent inspection, an iv cap was found seated in the "elbow" piece of the ventilator circuit. Both the iv cap and "elbow" are from the same manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6716900 |
| MDR Report Key | 6716900 |
| Date Received | 2017-07-17 |
| Date of Report | 2017-06-27 |
| Date of Event | 2017-06-23 |
| Date Facility Aware | 2017-06-23 |
| Report Date | 2017-06-27 |
| Date Reported to FDA | 2017-06-27 |
| Date Reported to Mfgr | 2017-06-27 |
| Date Added to Maude | 2017-07-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDLINE |
| Generic Name | ANESTHESIA VENTILATOR CIRCUIT |
| Product Code | OFP |
| Date Received | 2017-07-17 |
| Lot Number | 17QB5032, 00010334 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-07-17 |