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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG SENSIS VIBE HEMO; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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SIEMENS HEALTHINEERS AG SENSIS VIBE HEMO; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number 11007641
Device Problems No Display/Image (1183); No Device Output (1435)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/06/2023
Event Type  malfunction  
Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplement report will be filed if additional information becomes available.
 
Event Description
Siemens became aware of a malfunction that occurred while operating the sensis vibe hemo system.Prior to an emergency patient procedure, there was no display output.The failure caused a long-term delay of the emergency procedure.We have no indications of any adverse effects on the health status of the involved patient.
 
Manufacturer Narrative
The investigation was completed by our experts.The on-site service intervention identified a loose video adapter cable.Neither a defect in the cable nor why or how the cable became loose could be determined.As a preventive measure, the cable was replaced by siemens local service.The occurrence rate of the aforementioned error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.
 
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Brand Name
SENSIS VIBE HEMO
Type of Device
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
SIEMENS HEALTHINEERS AG
siemensstrasse 1 or
rittigfeld 1
forchheim 91301
GM  91301
Manufacturer (Section G)
SIEMENS HEALTHINEERS AG
siemensstrasse 1 -or
rittigfeld 1
forchheim 91301
GM   91301
Manufacturer Contact
anastasia sokolova
40 liberty blvd
malvern, PA 19355
4843234197
MDR Report Key18256642
MDR Text Key329608289
Report Number3004977335-2023-00157
Device Sequence Number1
Product Code DQK
UDI-Device Identifier04056869010199
UDI-Public04056869010199
Combination Product (y/n)N
Reporter Country CodeTC
PMA/PMN Number
K150493
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number11007641
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/30/2023
Initial Date FDA Received12/04/2023
Supplement Dates Manufacturer Received12/20/2023
Supplement Dates FDA Received12/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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