MAUDE Adverse Event Report: CAREFUSION/BD RESUS, ADLT W/MASK, RESV BAG, 6/CS; MANUAL EMERGENCY VENTILATOR

Catalog Number 2K8004

Device Problem Failure to Disconnect (2541)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2017

Event Type  Injury  

Manufacturer Narrative

It has been confirmed by carefusion/bd that the complaint sample is not available for evaluation.Attempts have been made by customer advocacy to gain additional information from the customer and end user regarding the situation reported with the device.Customer advocacy is still waiting for additional information regarding reported issue.If a sample or any additional information becomes available a follow up emdr will be submitted.(b)(4).

Event Description

Customer reported that the staff is not able to detach the mask from the bag.¿this has happened a few times to us at (b)(6).It is random, and has not caused any patient problems.I assumed someone had pushed the mask too far on to the bag and i wasn't strong enough to get it apart.One tech said that he had trouble disconnecting the bag from the endotracheal tube the end of the tube came apart when the bag was removed.Luckily there was a couple extra respiratory therapists there that fixed the issue very quickly¿.

Manufacturer Narrative

The following information should be removed from this report."the staff is not able to detach the mask from the bag.¿this has happened a few times to us at (b)(6).It is random, and has not caused any patient problems.I assumed someone had pushed the mask too far on to the bag and i wasn't strong enough to get it apart".This information is reflected in a different complaint.Customer advocacy is still waiting for additional information regarding reported issue.If a sample or any additional information becomes available a follow up emdr will be submitted.

Manufacturer Narrative

Follow up submission: 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.

Manufacturer Narrative

Corrected data: this complaint was re-evaluated during a complaint review.The roi has been revised to reflect the following corrected information.The failure mode reported was for the resuscitation bag elbow not disconnecting from an endotracheal tube.The capa referenced prior is not related to this reported failure mode.Unfortunately as stated prior vyaire did not receive a sample for a thorough evaluation; therefore the unable to disconnect failure mode could not be confirmed.Two years of complaint trends were reviewed and no trend was identified.At this time, no corrective actions will be implemented.

• Brand Name: RESUS, ADLT W/MASK, RESV BAG, 6/CS
• Type of Device: MANUAL EMERGENCY VENTILATOR
• Manufacturer (Section D): CAREFUSION/BD; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer (Section G): CAREFUSION/BD; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer Contact: mindy faber ; 75 n. fairway dr.; vernon hills, IL 60061
• MDR Report Key: 6397878
• MDR Text Key: 69737763
• Report Number: 8030673-2017-00303
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2K8004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2017
• Initial Date FDA Received: 03/11/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 10/27/2017
• Supplement Dates FDA Received: 04/05/2017; 04/21/2017; 11/08/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention