MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-14 for BALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER 109381603 manufactured by Avanos Medical Inc..
[177234406]
The actual complaint product was not returned for evaluation. A review of the device history record is in-progress. All information reasonably known as of 13-nov-2019 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).
Patient Sequence No: 1, Text Type: N, H10
[177234407]
Avanos medical, inc. Received a single report that referenced four different incidences, which were associated with separate units, involving four different events. This is the second of four reports. Refer to 3011270181-2019-00062 for the first event. Refer to 3011270181-2019-00064 for the third event. Refer to 3011270181-2019-00065 for the fourth event. It was reported the heat moisture exchange (mhe) was not fitting on the circuit with a tight fit. Additional information received 22-nov-2019 stated the event usually occurs between 2-hours and 6-hours during use. The vent alarm sounds when this occurs. The hme connection is simply reconnected to closed suction system (css) or changed out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011270181-2019-00063 |
| MDR Report Key | 9324399 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-14 |
| Date of Report | 2019-11-14 |
| Date Mfgr Received | 2019-10-18 |
| Date Added to Maude | 2019-11-14 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | AB ULAX |
| Manufacturer Street | MERKURIUSGATAN 8 OSTERGOTLANDS LAN SE-05 |
| Manufacturer City | MOTALA, SWEDEN 59132 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 59132 |
| 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 | 2019-11-14 |
| Model Number | 150 |
| Catalog Number | 109381603 |
| Lot Number | 2018-11-202019-04-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-11-14 |