MAUDE Adverse Event Report: GALEMED RESUS, ADLT, MASK,TUBE RESV,FLTR,10' TBG; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Catalog Number 2K7012

Device Problem Fitting Problem (2183)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Complaint sample has not been received.If samples become available and evaluation will be completed and a follow-up will be submitted.

Event Description

Recent (duplicate) safety incident of clinician hooking up the mask on the current airlife bag/valve/mask to the exhalation port.The mask is able to fit inside the exhalation filter quite comfortably and poses risk to the patient.The issue was recognized fairly quickly.However, the patients were ¿ventilated¿ for at least a minute with incorrect set up.As a result of professional intervention, compromise was avoided.

Manufacturer Narrative

(b)(4).Through the investigation conducted at the manufacturing site, the mask and filter were connected to the resuscitator with no issues.The probable root cause determined by the manufacturing site was that the mask was connected to the resuscitator incorrectly.The lot number that was provided was from a sample in the customer¿s inventory.The customer was unable to confirm if this was the same lot number that was on the actual product that was present when their reported issue occurred.A review of the device history record (dhr) was performed for the lot number that was provided.There were no issues identified with the material or manufacturing process that would have contributed to the reported issue.The customer has been provided instructions for use.

• Brand Name: RESUS, ADLT, MASK,TUBE RESV,FLTR,10' TBG
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): GALEMED; CH
• Manufacturer (Section G): GALEMED XIAMEN CO., LTD.; amoy export processing zone,39; section 3, haijing east road; xiamen fujian 36102 6; CH 361026
• Manufacturer Contact: mindy faber ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6425644
• MDR Text Key: 70624290
• Report Number: 2050001-2017-00054
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2K7012
• Device Lot Number: 160616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention