MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-23 for MARKET LAB ML20594 manufactured by Marketlab Incorporated.
[114711582]
This is on the deluxe titan draw cart #ml20594 from market lab. I was told by another employee that this happens with the other cart that is identical all of the time. I looked at the locking device and it is a blunt end bolt that just tightens onto the metal bar without any holes to lock into for safety. We have newer versions of this cart that are spring loaded with the same type of locking feature. Because they are spring loaded they do not drop this way. I feel that this is a poor design and major safety issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7710064 |
| MDR Report Key | 7710064 |
| Date Received | 2018-07-23 |
| Date of Report | 2018-06-19 |
| Date of Event | 2018-04-11 |
| Report Date | 2018-06-29 |
| Date Reported to FDA | 2018-06-29 |
| Date Reported to Mfgr | 2018-07-23 |
| Date Added to Maude | 2018-07-23 |
| 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 | MARKET LAB |
| Generic Name | DELUXE TITAN DRAW CART FOR BLOOD DRAWS |
| Product Code | BZN |
| Date Received | 2018-07-23 |
| Model Number | ML20594 |
| Catalog Number | ML20594 |
| Lot Number | MA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MARKETLAB INCORPORATED |
| Manufacturer Address | 6850 SOUTHBELT DR SE CALEDONIA MI 49316 US 49316 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-23 |