MAUDE Adverse Event Report: HOLOGIC, INC. SURESOUND; SOUND,UTERINE

Catalog Number NS2007 US

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 07/07/2015

Event Type  malfunction  

Event Description

The suresound device would not work.It gave a different reading each time we attempted to self-test.It was unplugged and plugged in approximately 5 times and would give different width readings every time.It wasn't the machine generator that was failing, because we got another suresound device to use with the same machine generator and it worked fine.

• Brand Name: SURESOUND
• Type of Device: SOUND,UTERINE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr.; marlborough MA 01752
• MDR Report Key: 5017617
• MDR Text Key: 23540376
• Report Number: 5017617
• Device Sequence Number: 1
• Product Code: HHM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/03/2016
• Device Catalogue Number: NS2007 US
• Device Lot Number: 15C03R
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 68