MAUDE Adverse Event Report: SUNMED HOLDINGS LLC. AIRFLOW; MANUAL RESUSCITATOR

Model Number S-AF5140MC-P

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Not Applicable (3189); Missing Value Reason (3192)

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

The batch record was reviewed and this was a small run of 5 parts for samples.Nothing abnormal was found during the review.The mask was manufactured in september 2016 (lot:160900093).The masks have a 5-year shelf life as well.The product was visually inspected and found to be within spec.The cushion was not completely inflated but still had enough air in it to form a seal around a patients face.The incoming inspection group in gr reviewed the sample and agreed this mask was ok.The mask was placed against a mannequin's face and shown to form a seal completely around the face.The mask was tested for leaks by placing the mask under water and looking for bubbles.No leaks were found in the mask.This confirms the mask functions as intended.

Event Description

The sales rep noticed that the "mask is deflated".No other details were provided and no patient involvement was reported.

• Brand Name: AIRFLOW
• Type of Device: MANUAL RESUSCITATOR
• Manufacturer (Section D): SUNMED HOLDINGS LLC.; 2710 northridge dr. nw; suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC.; 2710 northridge dr. nw; suite a; grand rapids MI 49544
• Manufacturer Contact: carrie fortuna ; 2710 northridge dr. nw.; suite a; grand rapids, MI 49544 ; 6162598400
• MDR Report Key: 7902801
• MDR Text Key: 121567777
• Report Number: 1314417-2018-00033
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: S-AF5140MC-P
• Device Lot Number: 307397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1