MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-21 for MEDICATION CART T5 LCD MCC manufactured by Enovate.
[50081259]
Patient Sequence No: 1, Text Type: N, H10
[50081260]
We have several hospital carts (some used in the dispensing of medication) with lithium-ion battery power that have constant battery problems throughout the hospital. Enovate has changed the batteries (contained in the power modules) and power modules - this has not resolved the issues. Enovate has not informed us of the problem. The hospital carts with battery power constantly shutdown on the nurses when they move them around the units. Manufacturer response for medication cart (per site reporter): they continue to send power modules and batteries. They have changed the model of the batteries and power modules but it has not worked.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 5811712 |
MDR Report Key | 5811712 |
Date Received | 2016-07-21 |
Date of Report | 2016-06-30 |
Date of Event | 2016-06-30 |
Report Date | 2016-06-30 |
Date Reported to FDA | 2016-06-30 |
Date Reported to Mfgr | 2016-06-30 |
Date Added to Maude | 2016-07-21 |
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 |
Brand Name | MEDICATION CART |
Generic Name | DISPENSER, SOLID MEDICATION |
Product Code | NXB |
Date Received | 2016-07-21 |
Model Number | T5 LCD MCC |
Operator | NURSE |
Device Availability | Y |
Device Age | 2 YR |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ENOVATE |
Manufacturer Address | 1152 PARK AVENUE MURFREESBORO TN 37129 US 37129 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2016-07-21 |