MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; AIRFLOW PEDIATRIC RESUSCITATOR WITH INTEGRATED MANOMETER

Model Number	AF2140MBP
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Decreased Level of Consciousness (4591)
Date of Event	06/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manual resuscitator may be the source of abnormal fico2 elevation.This is the issue that was referred to in the field.Notification initiated on oct 11, 2023.In addition, the fda medwatch report was received.
Event or Problem Description
Patient presentation: an unresponsive patient, helmeted driver of a motorcycle struck by another vehicle at a high rate of speed then struck and run over by an additional vehicle, was assessed with a glasgow coma scale (gcs) score of 3, indicative of severe consciousness impairment.Medical interventions: rapid sequence intubation (rsi) was performed to establish airway patency.The endotracheal tube (ett) was ventilated with an adult sunmed (af2140mbp) manual resuscitator with a manometer, positive end-expiratory pressure (peep) valve set at 5 cmh2o, heat and moisture exchange filter (hmfe), in-line end-tidal co2 (etco2) sensor and connected to a 15 l/min oxygen source.Fic02 elevation issue: while using the sunmed manual resuscitator, the patient's fraction of inspired co2 (fico2) levels increased until the clinical team placed the patient on a ventilator.This increase began at 14:38.36 (figure 1) and peaked at 20 mmhg at 14:42.13 (figure 2).Fico2 levels fluctuated between 10 and 20 mmhg (figure 3) until the patient was transitioned to a ventilator at 14:49.51.The elevation in fico2 resolved once the ventilator was initiated (figure 4).Product problem: suspicions arise that the manual resuscitator may be the source of the abnormal fic02 elevation.The fic02 increase poses a risk of hypercapnia, which can significantly impact the patient's bodily functions, physical well-being, and potentially lead to life-threatening consequences.Furthermore, this inconsistency raises concerns regarding adherence to performance specifications and user expectations.Patient outcome: the patients outcome is unknown, as care was handed over to another provider.
Additional Manufacturer Narrative
The manual resuscitator may be the source of abnormal fico2 elevation.This is the issue that was referred to in the field notification initiated on oct 11, 2023.In addition, the fda medwatch report was received.The complaint of "the manual resuscitator may be the source of abnormal fico2 elevation" regarding part af2140mbp was confirmed to be associated with ncmr-02506.A resolution letter was not requested by the customer.
Event or Problem Description
Patient presentation: an unresponsive patient, helmeted driver of a motorcycle struck by another vehicle at a high rate of speed then struck and run over by an additional vehicle, was assessed with a glasgow coma scale (gcs) score of 3, indicative of severe consciousness impairment.Medical interventions: rapid sequence intubation (rsi) was performed to establish airway patency.The endotracheal tube (ett) was ventilated with an adult sunmed (af2140mbp) manual resuscitator with a manometer, positive end-expiratory pressure (peep) valve set at 5 cmh2o, heat and moisture exchange filter (hmfe), in-line end-tidal co2 (etco2) sensor and connected to a 15 l/min oxygen source.Fic02 elevation issue: while using the sunmed manual resuscitator, the patient's fraction of inspired co2 (fico2) levels increased until the clinical team placed the patient on a ventilator.This increase began at 14:38.36 (figure 1) and peaked at 20 mmhg at 14:42.13 (figure 2).Fico2 levels fluctuated between 10 and 20 mmhg (figure 3) until the patient was transitioned to a ventilator at 14:49.51.The elevation in fico2 resolved once the ventilator was initiated (figure 4).Product problem: suspicions arise that the manual resuscitator may be the source of the abnormal fic02 elevation.The fic02 increase poses a risk of hypercapnia, which can significantly impact the patient's bodily functions, physical well-being, and potentially lead to life-threatening consequences.Furthermore, this inconsistency raises concerns regarding adherence to performance specifications and user expectations.Patient outcome: the patients outcome is unknown, as care was handed over to another provider.

• Brand Name: SUNMED LLC
• Common Device Name: AIRFLOW PEDIATRIC RESUSCITATOR WITH INTEGRATED MANOMETER
• 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: 18592409
• Report Number: 1314417-2024-00006
• Device Sequence Number: 8123530
• Product Code: BTM
• UDI-Device Identifier: 10889483088111
• UDI-Public: 10889483088111
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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: AF2140MBP
• Device Catalogue Number: AF2140MBP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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