MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-19 for GOMCO 6000 THERMOTIC SUCTION DRAINAGE PUMP manufactured by Medline Industries, Inc..
[127557797]
A patient need bi-lateral chest tube as well as an og tube in the resuscitation area. Both suction modules were being used for the chest tubes. I went to grab the portable suction unit and connect it to the og tube. When i turned on the machine the suction light turned on but it was not suctioning. I attempted to trouble shot the lack of suction but was unable to solve the issue. I left the suction connect, since the unit was below the patient it was at least able to work due to gravity. I went to our another area to get the new portable suction unit. I returned to resuscitation and connected the og tube and proceeded to successfully suction the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8083943 |
| MDR Report Key | 8083943 |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-09 |
| Date of Event | 2018-10-07 |
| Report Date | 2018-11-09 |
| Date Reported to FDA | 2018-11-09 |
| Date Reported to Mfgr | 2018-11-19 |
| Date Added to Maude | 2018-11-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | GOMCO 6000 THERMOTIC SUCTION DRAINAGE PUMP |
| Generic Name | PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) |
| Product Code | BTA |
| Date Received | 2018-11-19 |
| Model Number | 6000 |
| Catalog Number | 6000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-19 |