MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; AIR-Q DISPOSABLE 3.5

Model Number 10-3035

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Laceration(s) (1946)

Event Date 12/19/2023

Event Type  Injury  

Manufacturer Narrative

The patient had been harmed by the device.This could have been caused by improper use by the clinician or device malfunction.The device was not returned and how use of the device was not given within the initial report from customer.

Event Description

The patient had a hoarse voice after extubation.There was a subluxation of the left arytenoid cartilage.

Event Description

The patient had a hoarse voice after extubation.There was a subluxation of the left arytenoid cartilage.

Manufacturer Narrative

The patient had been harmed by the device.This could have been caused by improper use by the clinician or device malfunction.The device was not returned and how use of the device was not given within the initial report from customer.The complaint of "the mask of item 3.5 is too long and too large, resulting in patient harm " regarding part 10-3035 was not confirmed because there was no photo or sample returned.The root cause cannot be determined but could possibly be a result of "tracheal tube was used in a population other than specified" of "wrong size".A risk assessment was performed and the ultimate risk was determined to be low which does not require the initiation of a capa.There have been 3 other complaints against this part in the 24 months preceding this complaint.None of those complaints were regarding a similar issue.A resolution letter was sent to the customer.

• Brand Name: SUNMED LLC
• Type of Device: AIR-Q DISPOSABLE 3.5
• 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: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18628285
• MDR Text Key: 334369187
• Report Number: 1314417-2024-00010
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: 10-3035
• Device Catalogue Number: 10-3035
• Device Lot Number: 200583F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 01/02/2024
• Supplement Dates FDA Received: 02/23/2024
• 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): Other