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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE FINLAND OY E-SCAIO; ANALYZER, GAS, CARBON-DIOXIDE
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GE HEALTHCARE FINLAND OY E-SCAIO; ANALYZER, GAS, CARBON-DIOXIDE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Date 03/05/2021
Event Type  Injury  
Manufacturer Narrative
Ge healthcare's investigation of the described issue is ongoing at this time.A follow-up report will be submitted once the investigation has been completed.
 
Event Description
It was reported a trainee sustained a laceration requiring sutures while performing preventative maintenance on the device.
 
Manufacturer Narrative
Information for fields a2, a4-6 was requested but not provided.D4: device identification: (b)(4) or (b)(4).D4: unique identifier: (b)(4) or (b)(4).H4: (b)(6) 2017 and (b)(6) 2017.Investigation results: the customer site was supplied with two gas modules for training purposes; the customer could not identify which gas module was involved in the incident.Both gas modules were returned for further evaluation.No sharp edges were identified within either gas module.Review of the tools used during the training found no potential source of the laceration.No issues were identified with either gas module; root cause of the injury could not be determined.
 
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Brand Name
E-SCAIO
Type of Device
ANALYZER, GAS, CARBON-DIOXIDE
Manufacturer (Section D)
GE HEALTHCARE FINLAND OY
kuortaneenkatu 2
helsinki FIN-0 0510
FI  FIN-00510
MDR Report Key11574046
MDR Text Key242388210
Report Number9610105-2021-00001
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
PMA/PMN Number
K183394
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/05/2021
Initial Date FDA Received03/26/2021
Supplement Dates Manufacturer Received05/27/2021
Supplement Dates FDA Received05/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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