MAUDE Adverse Event Report: BOMIMED INC BOMIMED; LARYNGOSCOPE HANDLE

Model Number OL-334L6

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Cardiac Arrest (1762)

Event Date 05/31/2017

Event Type  malfunction  

Manufacturer Narrative

Device was not returned to bomimed for evaluation.

Event Description

Light source flickering non-functional at time of intubation.Report states the patient coded, but was stabilized with immediate intervention.No reported injury.

Manufacturer Narrative

Device was not returned to bomimed for evaluation.

Event Description

Light source flickering non-functional at time of intubation.Report states the patient coded, but was stabilized with immediate intervention.No reported injury.

• Brand Name: BOMIMED
• Type of Device: LARYNGOSCOPE HANDLE
• Manufacturer (Section D): BOMIMED INC; 1-100 irene street; winnipeg, manitoba R3T 4 E1; CA R3T 4E1
• Manufacturer (Section G): BOMIMED INC; 1-100 irene street; winnipeg, manitoba R3T 4 E1; CA R3T 4E1
• Manufacturer Contact: trina friesen ; 1-100 irene street; winnipeg, manitoba R3T 4-E1 ; CA R3T 4E1 ; 6332664
• MDR Report Key: 6708825
• MDR Text Key: 80036248
• Report Number: 3003213883-2017-00004
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Respiratory Therapist
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OL-334L6
• Device Catalogue Number: OL-334L6
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2017
• Initial Date FDA Received: 07/12/2017
• Supplement Dates Manufacturer Received: 05/31/2017
• Supplement Dates FDA Received: 08/08/2017
• 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
• Removal/Correction Number: 9071838-07/13/17-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention