MAUDE Adverse Event Report: SUNMED HOLDINGS, LLC VENTLAB; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number AF1140MB

Device Problem Deflation Problem (1149)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2018

Event Type  malfunction  

Event Description

Respiratory therapy staff informed director they needed to inflate the mask that comes with the ambu bags but they have been quite flat.Director looked at the er par level and identified 3 ambu bags total with the same issue.They were of the same lot # (310173) and manufactured on the same date and they seemed to deflate a bit over time.Director also checked the crash carts and found 2 additional ones with same lot #.Director removed them and took to supply chain.Replacements given.

• Brand Name: VENTLAB
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): SUNMED HOLDINGS, LLC; 2710 northridge drive nw suite a; grand rapids MI 49544
• MDR Report Key: 7845458
• MDR Text Key: 119236150
• Report Number: 7845458
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/23/2018,08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF1140MB
• Device Catalogue Number: AF1140MB
• Device Lot Number: 310173
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1