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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PUMP A127 GOFLO; INSUFFLATOR, HYSTEROSCOPIC
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SMITH & NEPHEW, INC. PUMP A127 GOFLO; INSUFFLATOR, HYSTEROSCOPIC Back to Search Results
Catalog Number T0449-01
Device Problem Infusion or Flow Problem (2964)
Patient Problem Swelling (2091)
Event Date 04/23/2018
Event Type  malfunction  
Manufacturer Narrative
Foreign zip code: (b)(6).
 
Event Description
It was reported that during a procedure the pump began to increase rate of flow with no adjustment having been made to the pressure setting, the patient's shoulder became moderately swollen (extravasated), the pressure was reduced to 20, the pump gradually began to push at an accelerated flow rate again, even with the pressure set at 20.No patient injury reported.
 
Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.
 
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Brand Name
PUMP A127 GOFLO
Type of Device
INSUFFLATOR, HYSTEROSCOPIC
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key7537307
MDR Text Key109043286
Report Number3003604053-2018-00077
Device Sequence Number1
Product Code HIG
Combination Product (y/n)N
PMA/PMN Number
K031616
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberT0449-01
Was Device Available for Evaluation? No
Date Manufacturer Received05/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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