MAUDE Adverse Event Report: RESPIRONICS, INC. CA E70 INTERNATIONAL; MECHANICAL INSUFFLATION/EXSUFFLATOR

Model Number	1098159
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging during the use of a cough assist device a pneumothorax occurred.There was no medical intervention reported.At this time, the device has not been returned to the manufacturer.A report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
H3 other text: device not returned to manufacturer.

• Brand Name: CA E70 INTERNATIONAL
• Common Device Name: MECHANICAL INSUFFLATION/EXSUFFLATOR
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17557963
• Report Number: 2518422-2023-19923
• Device Sequence Number: 11672551
• Product Code: BYI
• UDI-Device Identifier: 00606959005532
• UDI-Public: 00606959005532
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K122111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1098159
• Device Catalogue Number: 1098159
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown