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

Catalog Number 8570017

Device Problem Component Missing (2306)

Patient Problem Hypoxia (1918)

Event Date 10/09/2017

Event Type  Injury  

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".

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.

• Brand Name: MAKE, MANUAL RESUSCITATOR, ADULT, 1500 M
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): GALEMED; no.87, li-gong 2nd road; wu-jia, i-lan ; TW
• MDR Report Key: 7000219
• MDR Text Key: 90996831
• Report Number: 3010838917-2017-00038
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Health Professional
• 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 Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Catalogue Number: 8570017
• Device Lot Number: 20150302
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/13/2017
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2017
• Date Manufacturer Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention