MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-08-04 for CPRM1116 manufactured by Medline Industries Inc..
[6635716]
During administration of cpr to a resident who was in cardiac arrest, the swivel connector between the mouthpiece and the bag broke.
Patient Sequence No: 1, Text Type: D, B5
[14085755]
During administration of cpr to a resident who was in cardiac arrest, the swivel connector between the mouthpiece and the bag broke. The resident subsequently died. The vice president of clinical services stated that she could not confirm that the issue with the ambu bag caused or contributed to the resident's outcome. No sample was returned for evaluation. No lot number was provided. The root cause for the reported break of the swivel connector is not known. The overall condition of the ambu bag prior to use is also not known.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2015-00066 |
| MDR Report Key | 4964741 |
| Report Source | 05 |
| Date Received | 2015-08-04 |
| Date of Report | 2015-08-04 |
| Date Mfgr Received | 2015-07-08 |
| Date Added to Maude | 2015-08-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DIANE CHRISTENSEN |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | RESUSCITATOR |
| Product Code | NHK |
| Date Received | 2015-08-04 |
| Catalog Number | CPRM1116 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2015-08-04 |