MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCTS, INC. SHUCO-VAC; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Model Number 5711130

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 12/03/2016

Event Type  malfunction  

Event Description

During a cardiac resuscitation attempt, the suction machine on the crash cart stopped working.Wall suction was used after machine stopped.After the cardiac resuscitation event, the crash cart was taken to central supply and a new suction machine was placed on the cart.

• Brand Name: SHUCO-VAC
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS, INC.; 1720 sublette avenue; saint louis MO 63110
• MDR Report Key: 6180600
• MDR Text Key: 62557207
• Report Number: 6180600
• Device Sequence Number: 1
• Product Code: JCX
• 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: Other
• Type of Report: Initial
• Report Date: 12/05/2016,12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 5711130
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/05/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2016
• 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
• Patient Age: 58 YR