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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD 100S STERILIZER; STERRAD EQUIPMENT

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ADVANCED STERILIZATION PRODUCTS STERRAD 100S STERILIZER; STERRAD EQUIPMENT Back to Search Results
Model Number 10101
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/20/2020
Event Type  malfunction  
Manufacturer Narrative
A field service engineer was dispatched to the customer site.The vacuum pump oil, catalytic converter and oil mist filter were replaced to resolve the haze/mist issue.Unit meets specifications and was returned to service.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Asp complaint ref #: (b)(4).
 
Event Description
A customer reported an event of a "vapor seeping out" or a haze/mist emitting from the sterrad® 100s sterilizer.There was no report of any injuries or human reactions.The customer was advised to turn the unit off and leave the room.An asp field service engineer was dispatched to assess the unit onsite.This event is being reported as a malfunction report subsequent to a serious injury.
 
Manufacturer Narrative
H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the haze/mist issue, and system risk analysis (sra).¿the dhr was reviewed and no issues relating the failure mode were noted.The involved unit met manufacturer specifications at the time of release.¿trending analysis of the haze/mist issue for the sterrad® 100s unit was reviewed within the past six months and no significant trend was observed.¿the sra shows the risk for exposure to toxic or corrosive material to be "low." ¿ the parts were not available for return and further analysis.The assignable cause of the haze/mist issue is the vacuum pump oil, catalytic converter and oil mist filter.The field service engineer replaced these parts and confirmed the sterrad® 100s was restored to proper function after service.The issue was resolved at the customer facility.Asp will continue to track and trend this issue.Asp complaint ref #: cmp-(b)(4).
 
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Brand Name
STERRAD 100S STERILIZER
Type of Device
STERRAD EQUIPMENT
Manufacturer (Section D)
ADVANCED STERILIZATION PRODUCTS
33 technology drive
irvine CA
MDR Report Key10820532
MDR Text Key217110290
Report Number2084725-2020-50262
Device Sequence Number1
Product Code MLR
UDI-Device Identifier10705037014460
UDI-Public10705037014460
Combination Product (y/n)N
PMA/PMN Number
K991999
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10101
Device Catalogue Number10101
Device Lot NumberN/A
Was the Report Sent to FDA? Yes
Date Manufacturer Received11/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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