MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-08 for HYPERINFLATION SYSTEM 10-55800 manufactured by Mercury Medical.
[110495926]
Patient Sequence No: 1, Text Type: N, H10
[110495927]
Staff attempted the use of green bag and mask after delivery of pre-term baby. All connections came apart and green bag became disconnected from white plastic neck. The device was not able to be put back together. No harm to baby.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7581848 |
| MDR Report Key | 7581848 |
| Date Received | 2018-06-08 |
| Date of Report | 2018-06-07 |
| Date of Event | 2018-04-07 |
| Report Date | 2018-05-29 |
| Date Reported to FDA | 2018-05-29 |
| Date Reported to Mfgr | 2018-05-29 |
| Date Added to Maude | 2018-06-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYPERINFLATION SYSTEM |
| Generic Name | RESUSCITATOR,MANUAL,NON SELF-INFLATING |
| Product Code | NHK |
| Date Received | 2018-06-08 |
| Model Number | 10-55800 |
| Catalog Number | 10-55800 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERCURY MEDICAL |
| Manufacturer Address | 11300 49TH STREET NORTH CLEARWATER FL 33762 US 33762 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-08 |