MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-03 for BALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER 109381603 manufactured by Avanos Medical Inc..
[181735935]
The product involved in the report has been returned and is being processed for evaluation. A review of the device history record is in-progress. All information reasonably known as of 02-mar-2020 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. Avanos medical, inc. Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the avanos medical, inc. Complaint database and identified as complaint (b)(4). This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc. Product is defective or caused serious injury.
Patient Sequence No: 1, Text Type: N, H10
[181735936]
Avanos medical received a single report that referenced three different incidences, which were associated with separate units, involving three different events. This is the third of three reports. Refer to 3011270181-2020-00039 for the first event. Refer to 3011270181-2020-00040 for the second event. It was reported the heat and moisture exchanger attached to the end of the endotracheal tube (ett)and to the ventilator circuit disconnected during ventilation. There was no reported injury and the device was replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011270181-2020-00041 |
| MDR Report Key | 9779424 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-03-03 |
| 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 | MS. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | TRINITY MEDICAL DEVICES INC. |
| Manufacturer Street | 1 PLUCKEMIN WAY |
| Manufacturer City | BEDMINSTER NJ 07921 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07921 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER |
| Generic Name | VAP AIRWAY CIRCUIT DRAINS, HME & ACCESSORIES |
| Product Code | BYD |
| Date Received | 2020-03-03 |
| Returned To Mfg | 2020-02-14 |
| Model Number | 150 |
| Catalog Number | 109381603 |
| Lot Number | 2019-04-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVANOS MEDICAL INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-03 |