MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-19 for GOMCO 01-72-6000 manufactured by Allied Healthcare Products, Inc..
[131168478]
Unit has not been returned for evaluation. Label on unit and manual state "after the unit has been operating for four or five minutes, it will have exhausted the air from the collection bottle and the cylinder drainage will then start". We do not know if the unit was given enough time when started. They talk about using a red lid on the disposable collection unit. The unit shipped with a reusable bottle with a metal lid. We do not know how this collection unit works with our pump. Tubing had been cut and was not properly connected. It appeared to be spliced together. Any leaks in the tubing will effect the suction level. It appears the unit was not set up per specifications. And was not given time to get the air out of the system before using.
Patient Sequence No: 1, Text Type: N, H10
[131168479]
It was reported that a patient needed 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 shoot the lack of suction, but, was unable to solve the issue. I left the suction connected, since the unit was below the patient, it was at least able to work due to gravity. I went to another area to get the new portable suction unit. I returned to resuscitation and connected the og tube and preceded to successfully suction the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1924066-2018-00005 |
| MDR Report Key | 8182360 |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-10-07 |
| Date Mfgr Received | 2018-11-29 |
| Date Added to Maude | 2018-12-19 |
| 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 | MR. JON STILLMAN |
| Manufacturer Street | 1720 SUBLETTE AVE. |
| Manufacturer City | ST. LOUIS MO 63110 |
| Manufacturer Country | US |
| Manufacturer Postal | 63110 |
| Manufacturer Phone | 3142681616 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GOMCO |
| Generic Name | DRAINAGE PUMP |
| Product Code | BTA |
| Date Received | 2018-12-19 |
| Model Number | 01-72-6000 |
| Catalog Number | 01-72-6000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLIED HEALTHCARE PRODUCTS, INC. |
| Manufacturer Address | 1720 SUBLETTE AVE. ST. LOUIS MO 63110 US 63110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-19 |