MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LL; PEDI BAG W/MANOMETER & PEEP

Model Number	AF2140MBP
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The resuscitator had no pressure registering on the manometer while squeezing the resuscitation bag.This was an interruption in resuscitation efforts.The clinician was unable to provide ventilation to the patient and had to get a replacement resuscitation bag.
Event or Problem Description
Bags aren't holding pressure. .
Additional Manufacturer Narrative
The resuscitator had no pressure registering on the manometer while squeezing the resuscitation bag.This was an interruption in resuscitation efforts.The clinician was unable to provide ventilation to the patient and had to get a replacement resuscitation bag.Summary: returned product was tested and found to be in conformance.Customer was notified of performance and a video of the testing was shared.Ra: no risk associated with conforming product.
Event or Problem Description
Bags aren't holding pressure. .

• Brand Name: SUNMED LL
• Common Device Name: PEDI BAG W/MANOMETER & PEEP
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 17014849
• Report Number: 1314417-2023-00010
• Device Sequence Number: 12653887
• Product Code: NHK
• UDI-Device Identifier: 10889483088111
• UDI-Public: 10889483088111
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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
• Operator of Device: Health Professional
• Device Model Number: AF2140MBP
• Device Catalogue Number: AF2140MBP
• Device Lot Number: 394449,407356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown