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

Model Number 181863

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumothorax (2012)

Event Date 11/07/2018

Event Type  Injury  

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 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
• Type of Device: DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
• Manufacturer (Section D): HILL-ROM SINGAPORE; 1 yishun avenue 7; singapore, north east 76892 3; SN 768923
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 8137534
• MDR Text Key: 129470511
• Report Number: 3008145987-2018-00005
• Device Sequence Number: 1
• Product Code: NHJ
• UDI-Device Identifier: 00887761997387
• UDI-Public: 010088776199738711181029
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 181863
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 74