MAUDE Adverse Event Report: CAREFUSION, INC RESUS, PED W/MASK, LRG TBG, P/O, 6/CS; CARDIOPULMONARY RESUSCITATION AID KIT

Catalog Number 2K8018

Device Problem Failure to Disconnect (2541)

Patient Problems Apnea (1720); Low Oxygen Saturation (2477)

Event Date 01/31/2017

Event Type  Injury  

Manufacturer Narrative

Initial emdr submission: no sample available for this complaint.If any additional information becomes available a follow up submission will be filed.(b)(4).

Event Description

Customer reported the following via medwatch report (b)(4)."the patient had a desaturation episode to the 60's during a treatment.The respiratory therapist went to use the resuscitation bag and mask, but the mask size was wrong and it was not able to disconnect the mask from bag to switch to a different size.Customer confirmed that the mask was the wrong size for the patient but it was the mask that comes attached to the resuscitation bag the connector piece to the mask was stuck.The patient had an apneic event".

Manufacturer Narrative

No sample was provided for evaluation.At this time we are unable to confirm the reported issue.However, based on similar complaint investigations, a probable root cause is related to the current mirror finish surface on the elbow, which makes the mask very difficult to remove.Capa was opened to further investigate this issue.Capa (b)(4).The elbow will now contain a textured finish to allow the mask to be easily removed from the elbow.

• Brand Name: RESUS, PED W/MASK, LRG TBG, P/O, 6/CS
• Type of Device: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway dr; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer Contact: mindy faber ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6494308
• MDR Text Key: 72844847
• Report Number: 8030673-2017-00323
• Device Sequence Number: 1
• Product Code: OEV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: ENFORCEMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2K8018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention