MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA SEATTLE PAP; BREATHING HOSE , DISPOSABLE

Catalog Number MP02260

Device Problem Increase in Pressure (1491)

Patient Problem Pneumothorax (2012)

Event Date 02/23/2024

Event Type  Injury  

Event Description

It was reported that there might be a higher pressure value than the set/expected during using the seattle pap, which may have resulted in the pneumothorax of the patient.Reportedly the patient recovered and discharged from hospital by now.

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.

• Brand Name: SEATTLE PAP
• Type of Device: BREATHING HOSE , DISPOSABLE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 18985053
• MDR Text Key: 338660842
• Report Number: 9611500-2024-00130
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: MP02260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening