FDA Adverse Event
Malfunction
Summary report: N
SUNMED LLC
MDR report key: 13972930
·
Received April 1, 2022
Report
- Report Number
- 1314417-2022-00011
- Event Type
- Malfunction
- Date Received
- April 1, 2022
- Date of Event
- January 18, 2022
- Report Date
- March 31, 2022
- Manufacturer
- SUNMED LLC
- Product Code
- BTM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A BROKEN DEVICE DELAYED THEIR RESUSCITATION EFFORTS.
Additional Manufacturer Narrative · 0
A BROKEN DEVICE DELAYED THEIR RESUSCITATION EFFORTS. NO PRODUCT RETURNED, NO FURTHER EXPLANATION OF DEVICE FAILURE. CUSTOMER CONTACT MADE REQUESTING ADDITIONAL INFORMATION AND NONE COULD BE PROVIDED. CUSTOMER ACKNOWLEDGED THAT FURTHER INVESTIGATION COULD NOT BE COMPLETED WITHOUT ADDITIONAL INFORMATION. RA: RMA-20020 R37 "DEVICE CANNOT PERFORM AS INTENDED" IDENTIFIES POTENTIAL BROKEN RESUSCITATION BAGS NOT ABLE TO PERFORM AS INTENDED. NO UPDATE TO RMA REQUIRED.
Description of Event or Problem · 0
STAFF GETTING AMBU (RESUSCITATION) BAG READY FOR INTUBATION AND DEVICE BROKE.
Description of Event or Problem · 0
STAFF GETTING AMBU (RESUSCITATION) BAG READY FOR INTUBATION AND DEVICE BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1130680 | SUNMED LLC | SM ADULT W/MAN,MASK AND PEEP | BTM | SUNMED LLC | AF5140MBP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |