MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for MCKESSON DISPOSABLE HYPERINFLATION SYSTEM 1/2 L BAG 900000607 manufactured by Ambu, Inc..
[180894639]
Disposable ambu hyperinflation system 1/2 l green bag is consistently separating from white plastic piece that connects the bag to the mask for neonatal resuscitation. No harm to date but has a potential for harm. Noted by staff in the packaging bag when obtaining several of these items; none were useable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9753217 |
| MDR Report Key | 9753217 |
| Date Received | 2020-02-26 |
| Date of Report | 2020-01-14 |
| Date of Event | 2020-01-06 |
| Report Date | 2020-01-14 |
| Date Reported to FDA | 2020-01-14 |
| Date Reported to Mfgr | 2020-02-26 |
| Date Added to Maude | 2020-02-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | MCKESSON DISPOSABLE HYPERINFLATION SYSTEM 1/2 L BAG |
| Generic Name | VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) |
| Product Code | BTM |
| Date Received | 2020-02-26 |
| Catalog Number | 900000607 |
| Lot Number | 092719N02 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMBU, INC. |
| Manufacturer Address | 6230 OLD DOBBIN LN STE 250 COLUMBIA MD 21045 US 21045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |