MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-26 for OR510T manufactured by Medline.
[103455693]
Patient Sequence No: 1, Text Type: N, H10
[103455694]
The suction equipment malfunctioned in four rooms in the tower. Two icu's had difficulty maintaining adequate suction while intubating and during bronchoscopies. In one instance, one rn had to manually hold the suction canister closed during bronchoscopy. Materials management contacted and will need to follow up with manufacturer. Both lots returned to medline.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7369544 |
| MDR Report Key | 7369544 |
| Date Received | 2018-03-26 |
| Date of Report | 2018-03-12 |
| Date of Event | 2018-02-07 |
| Report Date | 2018-02-20 |
| Date Reported to FDA | 2018-02-20 |
| Date Reported to Mfgr | 2018-02-20 |
| Date Added to Maude | 2018-03-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Generic Name | TUBING, SUCTION |
| Product Code | BYY |
| Date Received | 2018-03-26 |
| Model Number | OR510T |
| Catalog Number | OR510T |
| Lot Number | (10)48617090001 |
| ID Number | SUCTION LINER #1000ML, LOT # |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | ONE MEDLINE PL. MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-26 |