MAUDE Adverse Event Report: SALTER LABS SALTER LABS; BX20 - MILLER 000 DISPOSABLE LED BLADE

Model Number 1040.C

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

Failure of device would delay intubation of the patient.

Event Description

One of the failures was found during intubation and delayed care was reported.

Manufacturer Narrative

Failure of device would delay intubation of the patient.Complaint history reviewed.There are no similar complaints for this issue in the last 24 months, issue is not trending.No remaining product to sort - customer had voiced concern that staff had used wrong bag - appears to be an isolated incident.Supplier has been notified.Risk (rma-20002b): r19: blade falls off handle - blade not properly engaged on handle - s=7, o=3, rpn=21.Rpn < 25 therefore risk is acceptable.

Event Description

One of the failures was found during intubation and delayed care was reported.

• Brand Name: SALTER LABS
• Type of Device: BX20 - MILLER 000 DISPOSABLE LED BLADE
• 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: 13983380
• MDR Text Key: 296777884
• Report Number: 3000219639-2022-00018
• Device Sequence Number: 1
• Product Code: CCW
• 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,Followup
• Report Date: 04/01/2022

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 Model Number: 1040.C
• Device Catalogue Number: 1040.C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 03/02/2022
• Supplement Dates FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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