MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-13 for RESUS, INF W/MASK, RESV BAG, P/O, 6/CS 2K8004 manufactured by Carefusion/bd.
[69841946]
(b)(4) has reached out to customer three times to provide the complaint device for further investigation. A (b)(6) label was also provided to the customer each time. Unfortunately, (b)(4) has not received the complaint device for evaluation or the requested additional information. The end-user has not responded to email or phone messages. Analyst had been attempting to find out if this incident actually happened with this product code. The customer reported the exact same incident with a different product code. The sales rep stated "it is my understanding it was am adult bag which is why it wasn? T more of an issue for them". We are conservatively reporting this incident as we are unable to verify this information with the end-user. If the sample or any additional information becomes available a follow up emdr will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[69841947]
Customer reported that the hospital is having issues. Staff is saying that it all has to do with them not being able to detach the mask from the bag. This has happened a few times to us at (b)(6). It is random, and has not caused any patient problems. I assumed someone had pushed the mask too far on to the bag and i wasn't strong enough to get it apart. One tech said that he had trouble disconnecting the bag from the endotracheal tube, the end of the tube came apart when the bag was removed. Luckily there was a couple extra rt's there that fixed the issue very quickly.
Patient Sequence No: 1, Text Type: D, B5
[73137257]
The following information should be removed from this report. "the staff is not able to detach the mask from the bag. ? This has happened a few times to us at (b)(6). It is random, and has not caused any patient problems. I assumed someone had pushed the mask too far on to the bag and i wasn't strong enough to get it apart". This information is reflected in a different complaint. Customer advocacy is still waiting for additional information regarding reported issue. If a sample or any additional information becomes available a follow up emdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[73596935]
Follow up submission: no sample was provided for evaluation. At this time we are unable to confirm the reported issue. However, based on similar complaint investigations, a probable root cause is related to the current mirror finish surface on the elbow, which makes the mask very difficult to remove. Capa was opened to further investigate this issue. Capa (b)(4). The elbow will now contain a textured finish to allow the mask to be easily removed from the elbow.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2017-00305 |
| MDR Report Key | 6401182 |
| Date Received | 2017-03-13 |
| Date of Report | 2017-10-13 |
| Date of Event | 2017-02-10 |
| Date Mfgr Received | 2017-07-07 |
| Date Added to Maude | 2017-03-13 |
| 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 N. FAIRWAY DR. |
| 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, INF W/MASK, RESV BAG, P/O, 6/CS |
| Generic Name | MANUAL EMERGENCY VENTILATOR |
| Product Code | OEV |
| Date Received | 2017-03-13 |
| Catalog Number | 2K8004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-03-13 |