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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SENIS VIBE HEMO LOW PROGRAMMABLE DIAGNOSTIC COMPUTER

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SIEMENS HEALTHCARE GMBH SENIS VIBE HEMO LOW PROGRAMMABLE DIAGNOSTIC COMPUTER Back to Search Results
Model Number 6634633
Device Problem Computer Software Problem (1112)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2021
Event Type  malfunction  
Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events. As this event is under investigation, a root cause has not yet been determined. A supplement report will be filed upon completion of the investigation. Internal id # (b)(4).
 
Event Description
It was reported to siemens that a malfunction occurred while operating the sensis vibe hemo low system. During an interventional procedure, the dialog monitor computer (dmc) stopped working. The procedure was continued and completed on an alternate system. We are unaware of any impact to the state of health of the patient involved. Siemens has requested additional information in order to conduct an investigation of the reported event. The reported event occurred in (b)(6).
 
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Brand NameSENIS VIBE HEMO LOW
Type of DevicePROGRAMMABLE DIAGNOSTIC COMPUTER
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
siemenstrasse 1
forchheim, 91301
GM 91301
Manufacturer (Section G)
SIEMENS HEALTHCARE GMBH-AT
siemensstr. 1
forchheim, germany 91301
GM 91301
Manufacturer Contact
meredith adams
40 liberty blvd.
mc 65-1a
malvern, PA 19355
6104486461
MDR Report Key12240136
MDR Text Key264596763
Report Number3004977335-2021-90348
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K150493
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Remedial Action Repair
Type of Report Initial,Followup
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6634633
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/28/2021 Patient Sequence Number: 1
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