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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SANDHILL SCIENTIFIC, INC. ZEPHR; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
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SANDHILL SCIENTIFIC, INC. ZEPHR; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) Back to Search Results
Model Number Z07-2000-B
Device Problems No Display/Image (1183); Loss of Data (2903)
Patient Problem No Code Available (3191)
Event Date 10/29/2017
Event Type  Injury  
Event Description
The study equipment was placed on patient and the study was started.When it was time for the study to end, the ph machine had a blank, lit blue screen and was unresponsive.Batteries were removed to turn off machine.The batteries were switched, the machine was turned back on, and machine was functional but had no record of ph/mcr study.There was no record of the study on the sd card either.The study data was lost and the test had to be repeated.Manufacturer response for ph monitoring device, zephyr ph monitoring system (per site reporter): exchanged part that was unrepairable.
 
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Brand Name
ZEPHR
Type of Device
SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
Manufacturer (Section D)
SANDHILL SCIENTIFIC, INC.
9150 commerce center cir ste 500
highlands ranch CO 80129
MDR Report Key7291704
MDR Text Key100768927
Report Number7291704
Device Sequence Number1
Product Code FFX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/29/2018,01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2018
Is this an Adverse Event Report? Yes
Device Operator Physician
Device Model NumberZ07-2000-B
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/29/2018
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer01/29/2018
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 Number1
Treatment
NO OTHER THERAPIES
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight4
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