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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEDI-40 INSTR. DEFECTIVE; ESR INSTRUMENT
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SEDI-40 INSTR. DEFECTIVE; ESR INSTRUMENT Back to Search Results
Catalog Number 36154608
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2021
Event Type  malfunction  
Manufacturer Narrative
In this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported when using the sedi-40 instr.Defective, the device experienced hardware / software malfunction for the esr instrument.The following information was provided by the initial reporter.The customer stated: instrument not powering on.
 
Event Description
It was reported when using the sedi-40 instr.Defective, the device experienced hardware / software malfunction for the esr instrument.The following information was provided by the initial reporter.The customer stated: instrument not powering on.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-10.Investigation summary: instrument sedi 40 15-42027 was returned to the manufacturer for service with respect to the reported defect ¿ no power.The instrument was evaluated by visual examination and functional testing and a loose dowel pin from the mixing block was found inside the instrument.This dowel pin likely created a short circuit on the driver board which caused the instrument to be unable to power on.The driver board was replaced and the mixing block was repaired.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
 
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Brand Name
SEDI-40 INSTR. DEFECTIVE
Type of Device
ESR INSTRUMENT
MDR Report Key12568266
MDR Text Key276183803
Report Number2243072-2021-02442
Device Sequence Number1
Product Code GHC
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number36154608
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2021
Date Manufacturer Received10/12/2021
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 Initial
Patient Sequence Number1
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