MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-14 for AQUILEX PUMP manufactured by Hologic, Inc.
[144956388]
The outflow tract would not function, it would not suck up. Checked device afterwards and seemed to be working. Manufacturer response for fluid management system, aquilex pump (per site reporter). Took the unit and shipped a replacement next day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8607316 |
| MDR Report Key | 8607316 |
| Date Received | 2019-05-14 |
| Date of Report | 2019-05-09 |
| Date of Event | 2019-04-12 |
| Report Date | 2019-05-09 |
| Date Reported to FDA | 2019-05-09 |
| Date Reported to Mfgr | 2019-05-14 |
| Date Added to Maude | 2019-05-14 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | AQUILEX PUMP |
| Generic Name | INSUFFLATOR, HYSTEROSCOPIC |
| Product Code | HIG |
| Date Received | 2019-05-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 250 CAMPUS DR. MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-14 |