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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON BREATHING CIRC,ANES,ADULT, 48 IN W/3 LT CIRCUIT, BREATHING (W CONNECTO

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TELEFLEX MEDICAL HUDSON BREATHING CIRC,ANES,ADULT, 48 IN W/3 LT CIRCUIT, BREATHING (W CONNECTO Back to Search Results
Model Number IPN049872
Device Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed and no relevant findings were identified. Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information. Teleflex will continue to monitor and trend for reports of this nature. If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
It was reported that "the breathing bag for anesthesia did not inflate during a pretest before use. Therefore, a new unit was used instead". No patient involvement reported.
 
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Brand NameHUDSON BREATHING CIRC,ANES,ADULT, 48 IN W/3 LT
Type of DeviceCIRCUIT, BREATHING (W CONNECTO
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key12381027
MDR Text Key268713870
Report Number3004365956-2021-00264
Device Sequence Number1
Product Code CAI
UDI-Device Identifier14026704641410
UDI-Public14026704641410
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN049872
Device Catalogue Number7140
Device Lot Number74G2000248
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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