MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-06 for CONTROLLER ASSY, CM 181863 manufactured by Hill-rom Singapore.
[129470511]
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.
Patient Sequence No: 1, Text Type: N, H10
[129470512]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008145987-2018-00005 |
| MDR Report Key | 8137534 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-06 |
| Date of Report | 2018-11-08 |
| Date of Event | 2018-11-07 |
| Date Mfgr Received | 2018-11-08 |
| Device Manufacturer Date | 2018-10-29 |
| Date Added to Maude | 2018-12-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TONY WERNER |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312359 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTROLLER ASSY, CM |
| Generic Name | DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT |
| Product Code | NHJ |
| Date Received | 2018-12-06 |
| Model Number | 181863 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM SINGAPORE |
| Manufacturer Address | 1 YISHUN AVENUE 7 SINGAPORE, NORTH EAST 768923 SN 768923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-06 |