MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED HOLDINGS LLC; SM ADULT W/MAN,MASK AND PEEP

Model Number	AF5140MBP
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	11/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was in critical condition in the icu requiring emergent intubation.Following administration of rsi drugs, bvm ventilation was carried out with noted chest rise this was the first use for the resuscitation bag.The patient was intubated and ventilation was resumed with resuscitation bag.The patient then began to deteriorate suddenly.Oxygen saturation was decreasing and breath sounds could not be verified.There was no chest rise.The endotracheal tube was visualized to be in proper position.It was noted that there was no pressure registering on the manometer while squeezing the resuscitation bag.The bag was disconnected and the bag was squeezed while occluding patient port.Again, there was no pressure measurement on the manometer.Staff obtained a replacement resuscitation bag and resumed ventilation with immediate improvement in the patient condition and chest rise and bilateral breath sounds were verified.Patient was stabilized after approximately 2 minutes of troubleshooting and time to obtain replacement resuscitation bag.There was no pressure registering on the manometer while squeezing the resuscitation bag.
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
The patient was in critical condition in the icu requiring emergent intubation.Following administration of rsi drugs, bvm ventilation was carried out with noted chest rise this was the first use for the resuscitation bag.The patient was intubated and ventilation was resumed with resuscitation bag.The patient then began to deteriorate suddenly.Oxygen saturation was decreasing and breath sounds could not be verified.There was no chest rise.The endotracheal tube was visualized to be in proper position.It was noted that there was no pressure registering on the manometer while squeezing the resuscitation bag.The bag was disconnected and the bag was squeezed while occluding patient port.Again, there was no pressure measurement on the manometer.Staff obtained a replacement resuscitation bag and resumed ventilation with immediate improvement in the patient condition and chest rise and bilateral breath sounds were verified.Patient was stabilized after approximately 2 minutes of troubleshooting and time to obtain replacement resuscitation bag.There was no pressure registering on the manometer while squeezing the resuscitation bag.
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 confirms complaint.Product was found to be missing a duckbill valve which prevented any pressure to be delivered to the patient port.Customer notified of defect, mitigation process outlined in ifu, and defect rates.Ra: risk assessment review of rma-20020, r37 identifies that missing components (like the tail assembly umbrella valve) are associated with a severity of 7.

• Brand Name: SUNMED HOLDINGS LLC
• Common Device Name: SM ADULT W/MAN,MASK AND 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 suire a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 15987832
• Report Number: 1314417-2022-00023
• Device Sequence Number: 17680020
• Product Code: BTM
• UDI-Device Identifier: 10889483074725
• UDI-Public: 10889483074725
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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
• Operator of Device: Health Professional
• Device Model Number: AF5140MBP
• Device Catalogue Number: AF5140MBP
• Device Lot Number: 2103291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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