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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF GERMANY (RWGMBH) INSUFFLATOR 45 HEAT FR 45L/MIN
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RICHARD WOLF GERMANY (RWGMBH) INSUFFLATOR 45 HEAT FR 45L/MIN Back to Search Results
Model Number 2235021
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/14/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation/evaluation currently in process as actual device returned to manufacturer.(b)(4) considers this report open, follow-up report to be submitted once investigation is complete.(b)(4).
 
Event Description
After patient was anesthetized, but prior to start of procedure, error code displayed on device.Procedure was then cancelled.
 
Manufacturer Narrative
(b)(4).Rwgmbh considers this case closed.Should additional information become available a follow up report will be submitted.
 
Event Description
Richard wolf medical instruments corporation (rwmic) received additional information from richard wolf gmbh (rwgmbh) on june 27, 2018.
 
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Brand Name
INSUFFLATOR 45 HEAT FR 45L/MIN
Type of Device
INSUFFLATOR
Manufacturer (Section D)
RICHARD WOLF GERMANY (RWGMBH)
32 pforzheimer street
knittlingen, 75438
GM  75438
MDR Report Key7347254
MDR Text Key102876433
Report Number9611102-2018-00005
Device Sequence Number1
Product Code HIF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 02/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number2235021
Device Catalogue Number2235021
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2018
Was the Report Sent to FDA? No
Date Manufacturer Received06/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age60 YR
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