FDA Adverse Event
Malfunction
Summary report: N
SUNMED HOLDINGS LLC
MDR report key: 14658778
·
Received June 10, 2022
Report
- Report Number
- 1314417-2022-00017
- Event Type
- Malfunction
- Date Received
- June 10, 2022
- Date of Event
- May 11, 2022
- Report Date
- June 10, 2022
- Manufacturer
- SUNMED HOLDINGS LLC
- Product Code
- BTL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 117
Narratives
Additional Manufacturer Narrative · 0
REPORTABLE AS THIS WOULD DELAY INTUBATION AND THERAPY ON INFANT PATIENT.
Additional Manufacturer Narrative · 0
REPORTABLE AS THIS WOULD DELAY INTUBATION AND THERAPY ON INFANT PATIENT. PRODUCT NOT RETURNED AND COMPLAINT COULD NOT BE CONFIRMED. COMPLAINT HISTORY REVIEWED FOR PRODUCT WITH ONE RELATED COMPLAINT ((B)(4)) AND FOUR UNRELATED COMPLAINTS FOR MASKS/POP-OFF. RA: RMA-20020 CONTAINS RISK ASSESSMENT FOR OXYGEN DELIVERY CONCERN.
Description of Event or Problem · 0
PRODUCT NOT CONSISTENTLY HOLDING PRESSURE.
Description of Event or Problem · 0
PRODUCT NOT CONSISTENTLY HOLDING PRESSURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1153547 | SUNMED HOLDINGS LLC | T-PIECE RESUSCITATOR W/ 7FT O2 TUBING, NO MASK | BTL | SUNMED HOLDINGS LLC | ST707 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |