MAUDE Adverse Event Report: CHEEN HOUNG ENT LTD AMBU RESCUE PUMP; MANUAL EMERGENCY SUCTION SYSTEM

Catalog Number 276001000

Device Problem Mechanical Jam (2983)

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 05/07/2020

Event Type  Injury  

Manufacturer Narrative

Investigations have been concluded for this reported issue by the manufacturer cheen houng enterprise.(b)(4) acts as distributer in the us.Only limited information was available.No sample was returned for investigation and no lot number was provided; therefore, the investigation is conducted based on the information given in the event description and experience and knowledge of the product.Possible root cause might be that the user tilted the device over 45 degrees during operation.The following safety information is given in the instructions for use of the device: the pump shall not be shaken while pumping or during use.The pump should not be tilted for the angles more than 45 degree while pumping or during use.If the pump handle becomes difficult to operate, a blockage may have occurred.Do not continue suctioning until the source of the blockage has been determined (remove the blockage from either the catheter, the adapter or the cap).Also disassembling the whole entire device is not a proper method of solving suction problem.Ifu clearly instructs in how to restore the suction ability without disassembling the whole device.The product risk evaluation includes the hazardous situation " no suction caused by a locked overfill protection due to user error ".The risk has been assessed with a severity of 3 (injury or impairment requiring professional medical intervention) and a probability of p=1 (occurs in <1/1.000.000).The risk is evaluated as acceptable and this incident does not change this conclusion.This mdr is resubmitted again as it was identified that original submission had not been successfully loaded into the fda database due to wrong file format.The initial mdr of this incident was submitted to the fda within the original reporting deadline.This submission represents a reload of data to ensure correct upload to the fda database.

Event Description

During cpr, airway suction was needed before intubation.But the pump did not work as supposed to which made suction difficult.When the device did not work the user disassembled and re-assembled the device before continuing with suction.By the user this can take a minute and in that time you can't do an airway suction of the patient to create free airway and enable intubation.

• Brand Name: AMBU RESCUE PUMP
• Type of Device: MANUAL EMERGENCY SUCTION SYSTEM
• Manufacturer (Section D): CHEEN HOUNG ENT LTD; 23 alley 11 lane 65; san dreen street; tapie, 23805 ; TW 23805
• MDR Report Key: 12046292
• MDR Text Key: 259360122
• Report Number: 1220828-2020-00006
• Device Sequence Number: 1
• Product Code: BSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 276001000
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention