MAUDE Adverse Event Report: LAERDAL MEDICAL AS LAERDAL SUCTION UNIT; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Device Problems Decrease in Suction (1146); Component or Accessory Incompatibility (2897)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2022

Event Type  malfunction  

Event Description

Patient being transported to ct scan.Patient had three chest tubes and was ordered to keep to suction.Due to supply chain issues, we recently switched to the atrium drainage system.The portable suction machines are not compatible with the atrium system.The portable suctions machine was not providing enough suction for the atrium system to work properly.Medical engineering tested the portable suction machines and found no problem with them.

• Brand Name: LAERDAL SUCTION UNIT
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): LAERDAL MEDICAL AS; 167 myers corners rd.; wappingers falls NY 12590
• MDR Report Key: 15592597
• MDR Text Key: 301735698
• Report Number: 15592597
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/29/2022,09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Race: American Indian Or Alaskan Native