MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-04-13 for RESUS, PED W/MASK, LRG TBG, P/O, 6/CS 2K8018 manufactured by Carefusion/bd.
[72778384]
Carefusion has received the complaint sample and is in the process of doing a full evaluation. 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
[72778385]
Customer reported the following via medwatch report number (b)(4) "the patient had a desaturation episode to the 60's during a treatment. The respiratory therapist went to use the resuscitation bag and mask, but the mask size was wrong and it was not able to disconnect the mask from bag to switch to a different size. Customer confirmed that the mask was the wrong size for the patient but it was the mask that comes attached to the resuscitation bag the connector piece to the mask was stuck. The patient had an apneic event".
Patient Sequence No: 1, Text Type: D, B5
[110217489]
One opened sample was returned for further evaluation. A visual inspection was performed and it was observed that the sample did not exhibit the textured surface finish on the connectors outer diameter. The textured surface makes it easier to detach the mask form the elbow. The prior design had a smooth mirror finish as exhibited on this sample. It was found that this mirror finish on the elbow and the smooth finish on the mask can create a vacuum effect making the removal of the mask difficult. A design change has been made to this product adding the texturized surface to the elbow eliminating the difficult remove failure mode.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2017-00321 |
| MDR Report Key | 6491298 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-13 |
| Date of Report | 2017-10-10 |
| Date of Event | 2017-01-31 |
| Date Mfgr Received | 2017-09-19 |
| Date Added to Maude | 2017-04-13 |
| 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, PED W/MASK, LRG TBG, P/O, 6/CS |
| Generic Name | CARDIOPULMONARY RESUSCITATION AID KIT |
| Product Code | OEV |
| Date Received | 2017-04-13 |
| Returned To Mfg | 2017-03-27 |
| Catalog Number | 2K8018 |
| 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 | 2017-04-13 |