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

Catalog Number 2K8004

Device Problems Failure to Disconnect (2541); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 02/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) has reached out to customer three times to provide the complaint device for further investigation.A (b)(6) label was also provided to the customer each time.Unfortunately, (b)(4) has not received the complaint device for evaluation or the requested additional information.The end-user has not responded to email or phone messages.Analyst had been attempting to find out if this incident actually happened with this product code.The customer reported the exact same incident with a different product code.The sales rep stated "it is my understanding it was am adult bag which is why it wasn¿t more of an issue for them".We are conservatively reporting this incident as we are unable to verify this information with the end-user.If the sample or any additional information becomes available a follow up emdr will be submitted.(b)(4).

Event Description

Customer reported that the hospital is having issues.Staff is saying that it all has to do with them not being 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 rt's 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

Upon complaint review and confirmation from the sales representative on 03/13/2017.The reported product code of 2k8021 was incorrect the product code is 2k8004.This complaint is a duplicate and will be closed.This reported incident for product code 2k8004 was submitted as an emdr on 03/10/2017, with a supplemental emdr on 04/21/2017.

• Brand Name: RESUS, INF W/MASK, RESV BAG, P/O, 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: 6401182
• MDR Text Key: 69841946
• Report Number: 8030673-2017-00305
• 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: 10/13/2017

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: 03/13/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 07/07/2017
• Supplement Dates FDA Received: 04/05/2017; 04/21/2017; 10/13/2017
• 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