MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-02-25 for COUGHT ASSIST 1098159 manufactured by Respironics Inc.
[5526127]
The manufacturer received information alleging a pediatric patient had major cervical surgery. Intubation was not possible. The reporting facility used a cough assist to ventilate the patient. The patient went into cardiac arrest and cardiopulmonary resuscitation was required. The patient is now in stable condition. There is no allegation of device malfunction that caused or contributed to the event. The device has yet to be returned to the manufacturer for evaluation. A follow up report will be submitted when the manufacturer has completed the investigation.
Patient Sequence No: 1, Text Type: D, B5
[13379281]
The manufacturer has completed the investigation of a cough assist that allegedly was being used to ventilate a pediatric patient after major cervical surgery. Intubation was not possible. The patient reportedly went into cardiac arrest and cardiopulmonary resuscitation was required. The patient is now in stable condition. There is no allegation of device malfunction that caused or contributed to the event. The cough assist device was evaluated by a third party service center. The cough assist was found to operate properly. There was no evidence of a malfunction that indicated a failure occurred. The manufacturer concludes the device operated to specifications. The device did not cause or contribute to the reported event. The cough assist's intended use states,"for use on any patient unable to cough or clear secretions effectively due to reduced peak cough expiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1040777-2015-00014 |
| MDR Report Key | 4546510 |
| Report Source | 01,05,06 |
| Date Received | 2015-02-25 |
| Date of Report | 2015-02-03 |
| Date of Event | 2015-01-19 |
| Date Mfgr Received | 2015-04-23 |
| Device Manufacturer Date | 2014-03-27 |
| Date Added to Maude | 2015-02-25 |
| 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 | MR. WILFREDO ALVAREZ |
| Manufacturer Street | 1740 GOLDEN MILE HIGHWAY |
| Manufacturer City | MONROEVILLE 15146 |
| Manufacturer Country | US |
| Manufacturer Postal | 15146 |
| Manufacturer Phone | 7243875658 |
| 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 |
| Generic Name | PERCUSSOR, POWERED-ELECTRIC |
| Product Code | BYI |
| Date Received | 2015-02-25 |
| Model Number | 1098159 |
| Catalog Number | 1098159 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-02-25 |