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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GALEMED MAKE, MANUAL RESUSCITATOR, ADULT, 1500 M VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

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GALEMED MAKE, MANUAL RESUSCITATOR, ADULT, 1500 M VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) Back to Search Results
Catalog Number 8570017
Device Problem Component Missing (2306)
Patient Problem Hypoxia (1918)
Event Date 10/09/2017
Event Type  Injury  
Manufacturer Narrative
Unfortunately the customer did not return the affected sample for further evaluation. The manufacture galemed did respond with a product quality investigation report off of all known information. The dhr was reviewed and no non-conformances were found. Manufacturing documents were reviewed and the quantity of the used duckbill valves were consistent with the quantity manufactured in this lot. Per the galemed manufacturing procedure after the duckbill valve is assembled on the nrv and connected to the resuscitator a 100% pressure test is executed. The acceptance criteria is a pressure maintained the validated pressure for 3 seconds under the condition of pressing the resuscitator body with the jig. A resuscitator without a duckbill valve would fail the test. Galemed stated "vyaire claimed the product was brand new but cannot be sure when it was sold to the hospital. This lot was sold from galemed in (b)(6) 2015 and it has passed over 2 years. The storage and transportation condition during the period from (b)(6) 2015 to (b)(6) 2017 cannot be controlled". Galemed reviewed the packaging process. The finished product, a resuscitator, was packaged with a zipper bag and then put into a unit box. These two package materials, a zipper bag and a unit box, could be re-opened and re-closed. User cannot detect if the product has been open or not. Based on the dhr and manufacturing process review without a sample the reported failure can not be confirmed. Galemed has also reported that there have been no similar incidents reported. Even though the failure could not be confirmed galemed has opened a capa to further evaluate this potential issue.
 
Manufacturer Narrative
To date, the device has not been provided for evaluation. The manufacturer has been made aware of this reported issue. If any additional information becomes available, a follow up report will be filed.
 
Event Description
"one part is missing from a new resuscitator. The patient was in icu and was just extubated but then needed intubation again. The doctor used at first a resuscitator (which was new from the pouch/box) but sp02 decreased and it was about 50 at the lowest. Reservoir bag inflated normally and the doctor and nurses didn´t notice at first that patient was not ventilated. They took another resuscitator from an adjacent place and it worked normally and could ventilate the patient. Later the nurse started to investigate the resuscitators and compared this resuscitator which didn´t work to a new one. She noticed duckpill valve, round blue rubbery part was missing. This was a new product. The customer suspects the product didn´t work because this part was missing".
 
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Brand NameMAKE, MANUAL RESUSCITATOR, ADULT, 1500 M
Type of DeviceVENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
Manufacturer (Section D)
GALEMED
no.87, li-gong 2nd road
wu-jia, i-lan
TW
MDR Report Key7000219
MDR Text Key267657080
Report Number3010838917-2017-00038
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/25/2017,01/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/01/2020
Device Catalogue Number8570017
Device Lot Number20150302
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date10/13/2017
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer10/25/2017
Date Manufacturer Received10/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/05/2015
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/03/2017 Patient Sequence Number: 1
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