MAUDE Adverse Event Report: AMBU INC SUN MED; DISPOSABLE HYPERINFLATION SYSTEM, BAG AND MANOMETER H2O POP-OFF VALVE

Model Number	900 000 614
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation a review of the device history record is in-progress.All information reasonably known as of 09 may 2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to sun med holdings llc.Sun med holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sun med holdings complaint database and identified as (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
It was reported, the pediatric patient experienced a delay in care due to the mis-assembly of the device (the bag was on the port for the mask and vice versa).The medical team gave the baby blow by while a different device was sourced.There was no reported injury.
Event or Problem Description
It was reported, the pediatric patient experienced a delay in care due to the mis-assembly of the device (the bag was on the port for the mask and vice versa).The medical team gave the baby blow by while a different device was sourced.There was no reported injury.
Additional Manufacturer Narrative
Correction: d3.Additional information-investigation conclusion: d4; h2; h6.The product involved in the report was not returned for evaluation; however, the failure mode was investigated and the root cause was determined to be manufacturing related; processes and procedures are in place to prevent its reoccurrence, which includes improvements to the final assembly fixture and staff retraining.The device history record for lot 491078 was reviewed and the product was produced according to product specifications.All information reasonably known as of 08 aug 2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to sun med holdings llc.Sun med holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sun med holdings complaint database and identified as (b)(4).This information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a sun med holdings llc.Product is defective or caused serious injury.

• Brand Name: SUN MED
• Common Device Name: DISPOSABLE HYPERINFLATION SYSTEM, BAG AND MANOMETER H2O POP-OFF VALVE
• Manufacturer (Section D): AMBU INC; 6230 old dobbin ln ste 250; ste a; columbia MD 21045
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544
• MDR Report Key: 21999640
• Report Number: 2028807-2025-00017
• Device Sequence Number: 9483957
• Product Code: BZR
• UDI-Device Identifier: 05707480137527
• UDI-Public: (01)05707480137527(10)491078(17)260610(11)240610
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K932709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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 Expiration Date: 06/10/2026
• Device Model Number: 900 000 614
• Device Lot Number: 491078
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 05/10/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown