MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-10-29 for COUGHT ASSIST T70 1098160 manufactured by Respironics Inc.
[29786602]
The manufacturer received information alleging a cough assist failed to operate with a detachable battery while traveling. The patient became cyanotic and cardiopulmonary resuscitation was administered. The patient was taken to the hospital by ambulance and was released from the hospital that evening. The device has yet to be returned to the manufacturer for evaluation. A follow up report will be filed when the manufacturer has completed the investigation.
Patient Sequence No: 1, Text Type: D, B5
[45982216]
The manufacturer previously reported a cough assist allegedly failed to operate with a detachable battery while traveling. The patient became cyanotic and cardiopulmonary resuscitation was administered. The patient was taken to the hospital by ambulance and was released from the hospital that evening. The device was returned to the manufacturer for evaluation. The device was tested and found to operate and alarm to design specifications. The manufacturer found the detachable battery that was being used with the device was observed to be depleted. The manufacturer was not able to confirm the charge level of the detachable battery at the time of the event. The detachable battery was returned to the manufacturer's quality assurance laboratory for further evaluation. During the investigation the root cause of the detachable battery being depleted and not charging was found to be due to a. 5vdc cell imbalance. The intended use of the device is for adult or pediatric patients unable to cough or clear secretions effectively. It may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. The device is intended to be used in the hospital, institutional environment, or in the home. Product labeling for the cough assist, t70, states, "you can operate the device using an external battery or the optional detachable battery. Note that the performance of the coughassist t70 while running on dc power may be affected depending on the state of the battery, the therapy settings, and patient airway resistance. " "when the external or detachable batteries are connected to the device, battery symbols will appear on-screen to indicate the battery status. The shading in the battery icon indicates the power remaining in the battery. " "the detachable battery cannot be charged. Replace battery. If problem persists with a different battery, contact your home care provider. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1040777-2015-00038 |
| MDR Report Key | 5186343 |
| Report Source | CONSUMER |
| Date Received | 2015-10-29 |
| Date of Report | 2015-10-01 |
| Date of Event | 2015-09-27 |
| Date Mfgr Received | 2016-05-24 |
| Device Manufacturer Date | 2013-08-30 |
| Date Added to Maude | 2015-10-29 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. WILFREDO ALVAREZ |
| Manufacturer Street | 312 ALVIN DRIVE |
| Manufacturer City | NEW KENSINGTON PA 15068 |
| Manufacturer Country | US |
| Manufacturer Postal | 15068 |
| Manufacturer Phone | 7243349303 |
| Manufacturer G1 | RESPIRONICS INC |
| Manufacturer Street | 175 CHASTAIN MEADOWS COURT |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COUGHT ASSIST T70 |
| Generic Name | PERCUSSOR, POWERED-ELECTRIC |
| Product Code | BYI |
| Date Received | 2015-10-29 |
| Returned To Mfg | 2016-03-14 |
| Model Number | 1098160 |
| Catalog Number | 1098160 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS INC |
| Manufacturer Address | 175 CHASTAIN MEADOWS COURT KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-10-29 |