MAUDE Adverse Event Report: HILL-ROM SINGAPORE CONTROLLER ASSY, CM; DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Model Number	181863
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	11/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient had copd and was using the metaneb device when they developed a small to moderate right pneumothorax and small left basilar pneumothorax that was treated with insertion of a chest tube and therefore meets the criteria of a serious injury.Development of pneumothoraxes occurs in individuals with significant underlying lung disease such as chronic obstructive pulmonary disease and is not indicative of a device malfunction.Per the instructions for use, the metaneb system is indicated for mobilization of secretions, lung expansion therapy, and the treatment and prevention of pulmonary atelectasis.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Event or Problem Description
Hill-rom received a report from the account stating the patient developed a small to moderate right pneumothorax and small left basilar pneumothorax.The device was located at the account.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: CONTROLLER ASSY, CM
• Common Device Name: DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
• Manufacturer (Section D): HILL-ROM SINGAPORE; 1 yishun avenue 7; singapore, north east 76892 3; SN 768923
• MDR Report Key: 8137534
• Report Number: 3008145987-2018-00005
• Device Sequence Number: 13854876
• Product Code: NHJ
• UDI-Device Identifier: 00887761997387
• UDI-Public: 010088776199738711181029
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K124032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2018

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: Other
• Device Model Number: 181863
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 12/06/2018
• 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: Other
• Patient Age: 72 YR
• Patient Weight: 74