MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-07 for LIFELINE EMERGENCY CART C05-990A manufactured by Intermetro Industries Corp..
[91517498]
Patient Sequence No: 1, Text Type: N, H10
[91517499]
Medication tray on top of crash cart is not secured by lock. About 4 months ago, it was reported that the top drawer containing the medication tray was not secure with the plastic lock in place on the new crash cart. Patient safety assessed the crash cart and noted: the top cavity security seal intact. The ability to push the top cover back and pull it up without breaking the security seal. Distribution was notified and was asked if it could be identified where this model cart was located within the hospital. Distribution would immediately change out the crash cart with the older model crash cart. Patient safety and pharmacy collaborated and went to distribution to come up with a plan. The manufacturer and distributor were contacted. The manufacturer provided the clinical product updates document addressing the issue. The distributor agreed to send a number of metro security seals (lec320) at no charge to trial. Lastly a similar security seal made by healthcare logistics, had been ordered. Replace as many of the newer crash carts with the older model until the newer model top cavity tray can be secured. Manufacturer response for crash cart, metro lifeline antimicrobial (per site reporter): attempt was made to talk to manufacturer and instead communication was with distributor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7006424 |
| MDR Report Key | 7006424 |
| Date Received | 2017-11-07 |
| Date of Report | 2017-09-14 |
| Date of Event | 2017-06-06 |
| Report Date | 2017-09-14 |
| Date Reported to FDA | 2017-09-14 |
| Date Reported to Mfgr | 2017-09-14 |
| Date Added to Maude | 2017-11-07 |
| 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 | PATIENT |
| 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 | 0 |
| Brand Name | LIFELINE EMERGENCY CART |
| Generic Name | CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) |
| Product Code | BZN |
| Date Received | 2017-11-07 |
| Model Number | C05-990A |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERMETRO INDUSTRIES CORP. |
| Manufacturer Address | WILLARD J SICKLES 651 N WASHINGTON ST WILKES BARRE PA 18705 US 18705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-07 |