MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-14 for CARE-E-VAC II 753790 manufactured by Hill-rom.
[80057768]
Patient Sequence No: 1, Text Type: N, H10
[80057769]
During a rapid response, attempts were made to use the suction machine from the code cart. The suction provided was inadequate and supplies were obtained for the wall suction. Code completed with wall suction.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 6714193 |
MDR Report Key | 6714193 |
Date Received | 2017-07-14 |
Date of Report | 2017-07-05 |
Date of Event | 2017-07-02 |
Report Date | 2017-07-05 |
Date Reported to FDA | 2017-07-05 |
Date Reported to Mfgr | 2017-07-05 |
Date Added to Maude | 2017-07-14 |
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 |
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 | CARE-E-VAC II |
Generic Name | PUMP, PORTABLE, ASPIRATION |
Product Code | BTA |
Date Received | 2017-07-14 |
Model Number | 753790 |
Device Availability | Y |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | HILL-ROM |
Manufacturer Address | 1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2017-07-14 |