MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-04-01 for COUGHASSIST 1006915 manufactured by Respironics Inc.,.
[1524406]
A parent reported an incident with a secretion clearing device, the coughassist, in which (b)(6) son experienced a decrease in oxygen saturation while receiving therapy. The parent alleged the device malfunctioned and "pushed too much air out. " the parent called 911 when she could not get the pt's oxygen saturation to return to baseline and he was subsequently hospitalized for four (4) days. The pt was diagnosed with a pneumothorax which was treated with the insertion of a chest tube. The parent reported that she was informed by someone at the hosp that the coughassist caused the pneumothorax. The alleged incident occurred on (b)(6) 2009. The mfr was made aware on march 3, 2010. The mfr's quality assurance (qa) dept received the coughassist for evaluation after being made aware of the incident. Qa could not confirm the device had malfunctioned and concluded that the device functioned according to specifications. The mfr did confirm the device had been set with parameters that did not include an inhalation breath to the pt, but rather multiple cycles of five (5) second negative pressure exhalation breaths. The "auto mode" setting caused the device to initiate fire (5) second exhalation breaths every three (3) seconds at negative (-) 40 centimeters of water pressure. The coughassist is a portable electric device which utilizes a blower and a valve to apply alternately a positive then negative pressure to a pt's airway in order to assist in clearing retained bronchopulmonary secretions. The therapy is delivered to the pt via a breathing circuit incorporating a flexible tube and bacterial filter. The pt interface for this therapy can be a facemask, a mouthpiece, or an adaptor to a tracheostomy or endotracheal tube. After 4 to 5 cough cycles, the interface should be removed from the pt, allowing time for a normal breathing pattern to return (20 to 30 seconds). A prolonged period of use of the coughassist is not recommended. Parameters must be prescribed by a physician only.
Patient Sequence No: 1, Text Type: D, B5
[8595439]
Results: inappropriate device settings. Quality assurance (qa) referred to the technical file for emerson coughassist models ca-3200 and cm-3200, section 5, risk mgmt, and determined the device labeling is adequate and appropriate. The user's guide, section 2 - warnings and cautions indicates the device should only be used by a trained professional to mitigate inappropriate pressure of times due to improper training. Based on all info available, the mfr asserts that the coughassist device performed as designed and exhibited no deficiencies in its design, quality, reliability, safe use, labelling or operation. In response to the determination the product was set incorrectly, the mfr does believe that product labelling and instructions for use are adequate to mitigate the risks associated with the device being set up incorrectly. The mfr concludes no further action is appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518422-2010-00025 |
| MDR Report Key | 1651924 |
| Report Source | 04 |
| Date Received | 2010-04-01 |
| Date of Report | 2010-03-03 |
| Date of Event | 2009-11-22 |
| Date Mfgr Received | 2010-03-03 |
| Device Manufacturer Date | 2003-10-01 |
| Date Added to Maude | 2011-04-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHERINE DEPADUA |
| Manufacturer Street | 1740 GOLDEN MILE HGWY |
| Manufacturer City | MONROEVILLE PA 15146 |
| Manufacturer Country | US |
| Manufacturer Postal | 15146 |
| Manufacturer Phone | 7243877770 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COUGHASSIST |
| Generic Name | SECRETION CLEARANCE DEVICE |
| Product Code | NHJ |
| Date Received | 2010-04-01 |
| Returned To Mfg | 2010-03-23 |
| Model Number | 1006915 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS INC., |
| Manufacturer Address | MURRYSVILLE PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2010-04-01 |