MAUDE Adverse Event Report: SALTER LABS SALTER LABS; PEDIATRIC DISPOSABLE HANDLE 3/BATTERY

Model Number 2016.C

Device Problem Material Integrity Problem (2978)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 09/15/2023

Event Type  malfunction  

Manufacturer Narrative

Failure of the device delayed the intubation of the patient.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.

Event Description

Would not light up. delay in intubation.The 1st and 2nd device did not light up, the 3rd device did work.

• Brand Name: SALTER LABS
• Type of Device: PEDIATRIC DISPOSABLE HANDLE 3/BATTERY
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 17978022
• MDR Text Key: 326183379
• Report Number: 3000219639-2023-00034
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00607411964428
• UDI-Public: 00607411964428
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2016.C
• Device Catalogue Number: 2016.C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/22/2023
• 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