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 2017-02-03 for CPRM1116 manufactured by Medline Industries.
[66465572]
During administration of cpr to a nursing home resident who was in cardiac arrest, it was reported the face mask did not create a good seal on the patients face. A second mask was retrieved and the same issue occurred. The resident was subsequently transported to the emergency department and died. The facility representative stated that she could not confirm that the issue with the ambu bag caused or contributed to the resident's outcome. An unused sample was returned. The root cause for the reported improper seal is not known. The overall condition of the ambu bag prior to use is also not known. In an abundance of caution this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[66465573]
During administration of cpr to a resident who was in cardiac arrest, it was reported the face mask did not create a good seal on the patients face.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2017-00003 |
| MDR Report Key | 6300075 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-03 |
| Date of Report | 2017-02-03 |
| Date Added to Maude | 2017-02-03 |
| 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. MEGAN DEBUS |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8477703962 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | RESUSCITATOR |
| Product Code | NHK |
| Date Received | 2017-02-03 |
| Catalog Number | CPRM1116 |
| Lot Number | 306996 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2017-02-03 |