MAUDE Adverse Event Report:

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Manufacturer Narrative

Date received by manufacturer of (b)(6) 2018 that was previously submitted under manufacturer report # 3005075696-2018-00020 was incorrect.The correct date received by manufacturer was (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

This event was previously reported.Refer to manufacturer report #3005075696-2018-00020.

• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9273888
• MDR Text Key: 174707729
• Report Number: 1723170-2019-05466
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K180307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2019
• Date Device Manufactured: 06/06/2017
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention