MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-02 for CPRM1116 manufactured by Medline Industries Inc..
[104274862]
It was reported that during a patient resuscitation event the swivel piece of the mask bag resuscitator broke off. The reported product issue occurred at the start of this event. A new mask bag resuscitator was obtained and the patient resuscitation event continued without further incident. The facility stated there was no impact or delay to the patient resuscitation event. There was no adverse effect noted or impact to the patient's stability. There was no change to the patient's plan of care. No serious injury, follow-up care, or medical intervention was reported. The sample was reportedly discarded and was not returned to the manufacturer for evaluation. Due to the reported incident and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[104274863]
It was reported that during a patient resuscitation event the swivel piece of the mask bag resuscitator broke off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00020 |
| MDR Report Key | 7389539 |
| Date Received | 2018-04-02 |
| Date of Report | 2018-04-02 |
| Date of Event | 2018-03-27 |
| Date Mfgr Received | 2018-03-29 |
| Date Added to Maude | 2018-04-02 |
| 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 | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | RESUSCITATOR,MANUAL,ADLT,MASK,BAG RES |
| Product Code | NHK |
| Date Received | 2018-04-02 |
| Catalog Number | CPRM1116 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-02 |