FDA Adverse Event
Injury
Summary report: N
RED LNC-1 PT CABLE
MDR report key: 4257525
·
Received November 5, 2014
Report
- Report Number
- 2031172-2014-00351
- Event Type
- Injury
- Date Received
- November 5, 2014
- Date of Event
- August 20, 2014
- Report Date
- October 6, 2014
- Manufacturer
- MASIMO CORPORATION
- Product Code
- DQA
- PMA / PMN Number
- K053477
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
MULTIPLE ATTEMPTS FOR PRODUCT RETURN AND REQUESTS FOR ADD'L INFO WERE MADE. THE CABLE HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF NEW INFO IS OBTAINED OR THE DEVICE IS RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT "MASIMO PORTABLE OXIMETER (RAD-57) DID NOT WORK DURING RESUSCITATION OF BABY; INTERMITTENT READINGS OF QUESTIONABLE RELIABILITY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 710134 | RED LNC-1 PT CABLE | OXIMETER | DQA | MASIMO CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |