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

Model Number AF5140MBP

Device Problem Material Integrity Problem (2978)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/02/2023

Event Type  malfunction  

Manufacturer Narrative

The patient was desaturated and was not receiving proper ventilation.

Event Description

The valve attached to the bvm was not functioning.The doctor was in the process of intubating this patient.The respiratory therapist was trying to bag the patient prior to the doctor placing the tube.The doctor was having some difficulty with the initial tube size.He opted to select a different size.At this time we noticed the patient's oxygen saturation started to drop.The respiratory therapist seemed to be having trouble getting a good seal with the bag valve mask.At this time patient care tech assisted in bagging while the respiratory therapist held a good ce clamp.The tech noticed the bag seemed to be a little easy to squeeze and we did not observe any chest rise while bagging.The patient's oxygen saturation continued to drop.The doctor then finished the intubation.The tech got another bag-valve-mask (bvm) from the omnicell.The patient's oxygen saturation immediately came up into the upper 90s.After completing the intubation staff checked the previous bvm.It appears the valve attached to the bvm was not functioning.It appeared the air coming through the bag entered the valve and came out between the valve and the bag instead of the exiting through the valve into the patient.Staff had saved the bag and turned it over to ed leadership for evaluation.

Manufacturer Narrative

The patient was desaturated and was not receiving proper ventilation.Summary: product was not returned and leak location could not be communicated from the customer.Potential root causes have been shared with the customer.Further investigation cannot be completed without returned devices.Ra: (b)(4) identifies risk id # (b)(4) with severity of 6 for leak to squeeze bag causing a decreased delivery of oxygen.

Event Description

The valve attached to the bvm was not functioning.The doctor was in the process of intubating this patient.The respiratory therapist was trying to bag the patient prior to the doctor placing the tube.The doctor was having some difficulty with the initial tube size.He opted to select a different size.At this time we noticed the patient's oxygen saturation started to drop.The respiratory therapist seemed to be having trouble getting a good seal with the bag valve mask.At this time patient care tech assisted in bagging while the respiratory therapist held a good ce clamp.The tech noticed the bag seemed to be a little easy to squeeze and we did not observe any chest rise while bagging.The patient's oxygen saturation continued to drop.The doctor then finished the intubation.The tech got another bag-valve-mask (bvm) from the omnicell.The patient's oxygen saturation immediately came up into the upper 90s.After completing the intubation staff checked the previous bvm.It appears the valve attached to the bvm was not functioning.It appeared the air coming through the bag entered the valve and came out between the valve and the bag instead of the exiting through the valve into the patient.Staff had saved the bag and turned it over to ed leadership for evaluation.

• Brand Name: SUNMED LLC
• Type of Device: 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 suite a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 17195277
• MDR Text Key: 318145993
• Report Number: 1314417-2023-00017
• Device Sequence Number: 1
• Product Code: BTM
• UDI-Device Identifier: 10889483074725
• UDI-Public: 10889483074725
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AF5140MBP
• Device Catalogue Number: AF5140MBP
• Device Lot Number: 397480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Male