MAUDE Adverse Event Report: HILL-ROM SINGAPORE METANEB 4 SYSTEM CAPITAL SALES; DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Model Number PMN4CAP

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

Patient Problem Pneumothorax (2012)

Event Date 02/25/2020

Event Type  Injury  

Manufacturer Narrative

The account in unable to confirm which device was used with this patient.Therefore, all three devices at the account were sent back to hillrom for inspection by a hillrom service technician.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.Possible adverse reactions include hyperventilation, gastric distension, decreased cardiac output, increased intracranial pressure, increased air trapping, hyperoxygenation, pneumothorax, pulmonary air leak, and pulmonary hemorrhage.A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on these devices.Based on the evaluation of the three devices that were sent back to hillrom and evaluated by a hillrom service technician, there was no evidence of a malfunction for all three devices.All devices were working as designed.Additionally, based on the information provided by the customer, it cannot be determined at this time if the metaneb device, used for treatment, caused or contributed to the patient¿s serious event.Shortness of breath is a main symptom of a pneumothorax and was also the patient¿s admitting diagnoses.The customer was unable to identify or confirm if the pneumothorax occurred prior to use of the device or during the use of the device.Based on this information, no further follow up is required.

Event Description

Hillrom received a report from the account stating the metaneb system potentially contributed to the patient¿s pneumothorax due to no preventative maintenance since 2017 on all three devices that the hospital owns.The patient was admitted on (b)(6) 2020 with shortness of breath that progressed to pneumonia.On (b)(6) 2020, the patient had a confirmed pneumothorax, after a chest x-ray was completed and was moved to the intensive care unit.Further information was requested by the account with unsuccessful attempts.A pneumothorax is also called a collapsed lung and is considered a serious injury.A pneumothorax can be caused by a blunt or penetrating chest injury, certain medical procedures, or damage from underlying lung disease.The main symptoms of a pneumothorax are sudden chest pain and shortness of breath.The devices were located at the account.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: METANEB 4 SYSTEM CAPITAL SALES
• 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: beth graceffa ; 1069 state route 46 east; batesville, IN 47006 ; 3122337700
• MDR Report Key: 9878238
• MDR Text Key: 196436745
• Report Number: 3008145987-2020-00001
• Device Sequence Number: 1
• Product Code: NHJ
• UDI-Device Identifier: 00887761997387
• UDI-Public: 010088776199738711171201
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PMN4CAP
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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: 57 YR