MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-08 for MEDI-VAC GUARDIAN 65651-230 manufactured by Cardinal Health.
[39857500]
Patient Sequence No: 1, Text Type: N, H10
[39857501]
We have had three incidents in the past year. This report centers on the first incident listed below. I will include additional details about the other two incidents in this section. I do not have patient specific information on the second two incidents. The suction canister was connected to wall suction. Wall suction was on. It is assumed that the tubing from the "patient" nozzle was clamped but that cannot be confirmed. Staff report the canister spontaneously "exploded sending pieces of plastic flying". The implosion was loud. No injuries. The suction canister was connected to wall suction. Wall suction was on. It is assumed that the tubing from the "patient" nozzle was clamped but that cannot be confirmed. The canister was bumped by the stretcher as the patient was rolled in for the procedure and it imploded. No injuries. The suction canister was connected to wall suction. Wall suction was on. It is known that the tubing from the "patient" nozzle was clamped. The canister spontaneously imploded. No injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5485564 |
| MDR Report Key | 5485564 |
| Date Received | 2016-03-08 |
| Date of Report | 2016-02-23 |
| Date of Event | 2015-02-19 |
| Report Date | 2016-02-23 |
| Date Reported to FDA | 2016-02-23 |
| Date Reported to Mfgr | 2016-02-23 |
| Date Added to Maude | 2016-03-08 |
| 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 | 0 |
| 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 | MEDI-VAC GUARDIAN |
| Generic Name | APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED |
| Product Code | OJR |
| Date Received | 2016-03-08 |
| Catalog Number | 65651-230 |
| ID Number | 3000ML |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1500 WAUKEGAN ROAD WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-08 |