MAUDE Adverse Event Report: SUNMED HOLDINGS, LLC. MANUAL RESUSCITATOR BAGS

Device Problems Detachment Of Device Component (1104); Nonstandard Device (1420); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

On (b)(4) 2018, sunmed holdings, llc initiated a nationwide recall of (b)(4) units of stat-check and medline resuscitator bags which were distributed between 02/01/2018 to 05/13/2018.The patient port retaining ring of the affected bags may not fully seat which may allow the patient port to detach during use.If this takes place, the resuscitator bags may not deliver air to the patient and result in a delay in treatment and life-threatening health consequences.There have been no reported injuries to date.

• Brand Name: MANUAL RESUSCITATOR BAGS
• Type of Device: MANUAL RESUSCITATOR BAGS
• Manufacturer (Section D): SUNMED HOLDINGS, LLC.
• MDR Report Key: 7582231
• MDR Text Key: 110641573
• Report Number: MW5077701
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1