MAUDE Adverse Event Report: PRECISION MEDICAL EASY GO VAC ASPIRATOR

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problem No Information (3190)

Event Date 08/26/2017

Event Type  Injury  

Event Description

Reporter is reporting on behalf of her husband who has a stage four cancer and has a tracheostomy which needed to be suctioned.Two precision medical machines were delivered for suctioning.At the time of delivery there were no instructions on how to use the machines and her husband was not home to try the machines himself.Reporter called the suppliers and they promised to send an email with the instructions but the email was never received.Reporter stated these machines are not operational since there are no instructions.One of the machines the easy air compressor cup fell off the machine and they could not put it back together because there are no instructions on how to use or fix it.A service call was placed for replacement of the suction cup but they could not put it together or operate the machine.They are still experiencing problems with these machines.She believes it is a scam since the delivery person keep coming to her house with the pretence of delivering parts of these machines but the machines are still non operational.

• Brand Name: EASY GO VAC ASPIRATOR
• Type of Device: EASY GO VAC ASPIRATOR
• Manufacturer (Section D): PRECISION MEDICAL
• MDR Report Key: 6826751
• MDR Text Key: 83971864
• Report Number: MW5071814
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/28/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: ITEM ID #E0600
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR