MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-04-04 for RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS 2K8032 manufactured by Carefusion/bd.
[71680103]
Customer advocacy has reached out to customer to provide sample for the investigation. Ups label was provided to the customer. At this time we are currently waiting for the sample. Once the investigation is complete or if we receive any additional information we will provide a follow up emdr. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[71680104]
Customer reported "air leak on valve when used on a patient, there was no patient harm. The end-user noticed an air leak on the bag and it does not provide full ventilation to the patient during intubation. They used a new resuscitation bag to complete the procedure since they noticed instantly that there was an air leak and the bag could not provide full ventilation to the patient".
Patient Sequence No: 1, Text Type: D, B5
[110216980]
One opened sample was received for evaluation. A leak test was performed and the device failed the leak test. The leak was present at the blue balloon. A lack of uv glue was observed at this area causing the reported leak. A dhr review was conducted and no issues were found. 2-years of complaints were reviewed and no trend was detected relating to this issue. The probable root cause of this issue is related to process/method error due to inconsistent uv glue application and the failure of personnel to perform the 100% post curing inspection as described in the procedure. A capa (b)(4) was implemented relating to this issue. Corrective actions performed: uv glue dispensing system changed, operators were certified to apply the adhesive, personnel were retrained in 100% post curing inspection, preventative maintenance was updated to include monthly inspection of the uv device glass with bulb replacement every 3 months.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2017-00316 |
| MDR Report Key | 6457343 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-04-04 |
| Date of Report | 2017-08-04 |
| Date of Event | 2017-02-19 |
| Date Mfgr Received | 2017-07-04 |
| Date Added to Maude | 2017-04-04 |
| 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 | MINDY FABER |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION/BD |
| Manufacturer Street | CERRADA V NO.85 PARQUE INDUSTRIAL |
| Manufacturer City | MEXICALI BAJA CALIFORNIA NORTE |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS |
| Generic Name | MANUAL EMERGENCY VENTILATOR |
| Product Code | OEV |
| Date Received | 2017-04-04 |
| Returned To Mfg | 2017-04-21 |
| Catalog Number | 2K8032 |
| Lot Number | 0000816138 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION/BD |
| Manufacturer Address | CERRADA V?A DE LA PRODUCCI?N NO.85 PARQUE INDUSTRIAL MEXICALI BAJA CALIFORNIA NORTE MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-04 |