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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. GIBECK ISO-GARD FILTER SMALL S, TETHERED CAP; BREATHING CIRCUIT BACTERIAL FILTER
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TELEFLEX MEDICAL SDN. BHD. GIBECK ISO-GARD FILTER SMALL S, TETHERED CAP; BREATHING CIRCUIT BACTERIAL FILTER Back to Search Results
Model Number IPN043788
Device Problem Obstruction of Flow (2423)
Patient Problems Low Blood Pressure/ Hypotension (1914); No Consequences Or Impact To Patient (2199)
Event Date 12/06/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer reported the patient's tidal volume decreased to 250 mls and sao2 to 96% resulting in a drop in blood pressure to 89/40 and increased co2 to 9.5 kpa (kilopascal).The filter was changed and the issue resolved.No further issues or injury to patient reported after filter was changed.Patient was reported to be in critical condition due to a c4 complete tetraplegia.
 
Manufacturer Narrative
(b)(4).The actual sample was returned along with 26 representative samples.A visual exam was performed and there were no defects observed.Leak and drop testing was conducted on the representative samples and no issues were encountered.Testing could not be performed on the actual returned sample as it had been used.A device history record review was performed and no relevant findings were identified.In the current manufacturing procedure 100% leak testing and visual inspection is conducted after the assembly process; thus any defective product would be detected prior to release from the manufacturing facility.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the actual sample or the representative samples that were returned.
 
Event Description
Customer reported the patient's tidal volume decreased to 250 mls and sao2 to 96% resulting in a drop in blood pressure to 89/40 and increased co2 to 9.5 kpa (kilopascal).The filter was changed and the issue resolved.No further issues or injury to patient reported after filter was changed.Patient was reported to be in critical condition due to a c4 complete tetraplegia.
 
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Brand Name
GIBECK ISO-GARD FILTER SMALL S, TETHERED CAP
Type of Device
BREATHING CIRCUIT BACTERIAL FILTER
Manufacturer (Section D)
TELEFLEX MEDICAL SDN. BHD.
perak, west malaysia
MDR Report Key9553341
MDR Text Key173780488
Report Number8040412-2020-00004
Device Sequence Number1
Product Code CAH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Type of Report Initial,Followup
Report Date 12/18/2019
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? Yes
Device Operator No Information
Device Model NumberIPN043788
Device Catalogue Number19512TN
Device Lot Number201932
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2020
Initial Date Manufacturer Received 12/18/2019
Initial Date FDA Received01/06/2020
Supplement Dates Manufacturer Received01/31/2020
Supplement Dates FDA Received01/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED; NONE REPORTED; NONE REPORTED
Patient Outcome(s) Required Intervention;
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