MAUDE Adverse Event Report: INTERMETRO INDUSTRIES CORP. LIFELINE EMERGENCY CART; CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)

Model Number C05-990A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 06/06/2017

Event Type  malfunction  

Event Description

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.

• Brand Name: LIFELINE EMERGENCY CART
• Type of Device: CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)
• Manufacturer (Section D): INTERMETRO INDUSTRIES CORP.; willard j sickles; 651 n washington st; wilkes barre PA 18705
• MDR Report Key: 7006424
• MDR Text Key: 91517499
• Report Number: 7006424
• Device Sequence Number: 1
• Product Code: BZN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: C05-990A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1