MAUDE Adverse Event Report: DR. JOEL KAPLAN INC MEDICAL VACUUM PUMP

Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2014

Event Type  malfunction  

Event Description

About 6 months earlier, pt purchased a medical vacuum pump but it had a malfunction.After contacting the manufacturer, a replacement was sent.So far all has been well until last thursday ((b)(6) 2014).After using the device and was about to put it away, the gauge fell off.Manufacturer was again contacted but this time they refused to send a replacement claiming that the device wasn't bought directly from them.Pt has suffered no injuries but would like a refund.

• Brand Name: MEDICAL VACUUM PUMP
• Type of Device: MEDICAL VACUUM PUMP
• Manufacturer (Section D): DR. JOEL KAPLAN INC
• MDR Report Key: 3846084
• MDR Text Key: 4684984
• Report Number: MW5036431
• Device Sequence Number: 1
• Product Code: LKY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1