• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESPIRE 7100 ANESTHESIA GAS MACHINE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AESPIRE 7100 ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Gas Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/18/2021
Event Type  malfunction  
Manufacturer Narrative
No report of patient involvement. The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. The distributor performed a checkout of the equipment and confirmed the reported complaint. The o2 pressure sensor switch was replaced to resolve the issue. Legal manufacturer: hcs madison - (b)(4).
 
Event Description
The hospital reported a pressure leak from the pressure sensor switch resulting in loss of mechanical ventilation. There was no patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAESPIRE 7100
Type of DeviceANESTHESIA GAS MACHINE
MDR Report Key12631534
MDR Text Key278762136
Report Number9710602-2021-00316
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial
Report Date 10/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/18/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/21/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-