FDA Adverse Event
Injury
Summary report: N
PIC IX HARDWARE
MDR report key: 11798227
·
Received May 10, 2021
Report
- Report Number
- 1218950-2021-10518
- Event Type
- Injury
- Date Received
- May 10, 2021
- Date of Event
- May 7, 2021
- Manufacturer
- PHILIPS NORTH AMERICA LLC
- Product Code
- MHX
- PMA / PMN Number
- K102495
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
DO TO INCORRECT PRODUCT AND REGISTRATION NUMBER A NEW REPORT HAS BEEN GENERATED. PLEASE REFER TO 9610816-2021-10257 FOR COMPLETE REPORT.
Additional Manufacturer Narrative · 1
A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THEIR CENTRAL STATION WAS EMITTING YELLOW ALARMS WHEN THE ALARM SHOULD HAVE BEEN RED. THE ALARM DISCREPANCY RESULTED IN ONE PATIENT NEEDING TO BE INTUBATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 693166 | PIC IX HARDWARE | PIC IX HARDWARE | MHX | PHILIPS NORTH AMERICA LLC | 866424 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |