MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-02-01 for ASSY,CONTROLLER,VITAL COUGH M06563 manufactured by Hill-rom Singapore.
[134712101]
The customer alleged that during a vitalcough treatment, the (b)(6) old infant started to choke and turn blue. The mom called for emergency assistance and attempted to clear the infant? S airway. The infant was assessed by emergency services and they determined that the infant? S oxygen level was normal and required no additional treatment at that time. Three days after the event of choking, the infant was admitted to the hospital with a diagnosis of aspiration pneumonia and was subsequently discharged two days later. The infant? S medical history and need for home suctioning indicates a known inability to manage and clear secretions. A subsequent follow-up with the patient? S pulmonologist occurred. The pulmonologist ordered continuation of the vitalcough therapy as he believes it is of benefit to the infant. The vitalcough is intended to stimulate cough to remove secretions in patients with compromised peak flow. The device worked as intended. The infant? S choking is most likely related to his underlying pathology (hypotonia, need from home suctioning and history of pulmonary aspiration). The patient has a past history of hypotonia, pulmonary aspiration and use of home suctioning; however the direct cause of the aspiration pneumonia is unknown. As the direct cause of the aspiration pneumonia is unknown, it is possible that device may have caused or contributed to the event and therefore will be conservatively reported as a serious injury.
Patient Sequence No: 1, Text Type: N, H10
[134712102]
Hill-rom received a report from the account stating the patient developed aspiration pneumonia. The device was located at the user's home. This report was filed in our complaint handling system as complaint # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008145987-2019-00001 |
| MDR Report Key | 8296463 |
| Report Source | CONSUMER |
| Date Received | 2019-02-01 |
| Date of Report | 2019-01-03 |
| Date of Event | 2018-12-25 |
| Date Mfgr Received | 2019-01-03 |
| Device Manufacturer Date | 2018-04-20 |
| Date Added to Maude | 2019-02-01 |
| 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 | 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 | ASSY,CONTROLLER,VITAL COUGH |
| Generic Name | DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT |
| Product Code | NHJ |
| Date Received | 2019-02-01 |
| Model Number | M06563 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-02-01 |