MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX 1ST RESPONSE MANUAL RESUSCITATOR; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Catalog Number 8520BM

Device Problem Failure to Deliver (2338)

Patient Problems Low Oxygen Saturation (2477); Decreased Respiratory Rate (2485); Respiratory Insufficiency (4462)

Event Date 09/23/2022

Event Type  malfunction  

Manufacturer Narrative

Udi is unknown, no product information has been provided to date.Expiration date and manufacture date are unknown.No information is available based on reported lot number.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that a medical team used material with the correct technique and adequate face mask size, however, the ventilation maneuver was inadequate, as the bag did not generate enough pressure and the child's chest did not expand and did not recover spo2.

Manufacturer Narrative

No product sample was received; therefore, visual and functional testing could not be performed.A review of manufacturing device history records found no discrepancies or anomalies.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.No actions have been taken at this time.

• Brand Name: PORTEX 1ST RESPONSE MANUAL RESUSCITATOR
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16461321
• MDR Text Key: 310447289
• Report Number: 3012307300-2023-01824
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K014115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8520BM
• Device Lot Number: 181203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1