FDA Adverse Event
Injury
Summary report: N
PATIENT INFORMATION CENTER IX
MDR report key: 12066139
·
Received June 25, 2021
Report
- Report Number
- 1218950-2021-10676
- Event Type
- Injury
- Date Received
- June 25, 2021
- Date of Event
- June 17, 2021
- Manufacturer
- PHILIPS NORTH AMERICA LLC
- Product Code
- MHX
- UDI-DI
- 00884838093041
- PMA / PMN Number
- K153702
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE WITH THE CUSTOMER AND LOGS WERE RETRIEVED. A REVIEW OF THE AUDIT LOGS FOUND SEVERAL ACKNOWLEDGEMENTS OVER THE REPORTED TIME PERIOD. THERE WAS NO PRODUCT MALFUNCTION; THIS IS CONSIDERED A USER ISSUE. INFORMATION WAS PROVIDED TO THE CUSTOMER. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.
Description of Event or Problem · 0
THE CUSTOMER REPORTED: PATIENT INCIDENT. PLEASE COLLECT DATA ON WHETHER AN ALARM WAS ACKNOWLEDGED. ERROR OCCURRED ON: (B)(6) TO (B)(6), PRIMARY PERIOD FROM 4:00 AM - 6:00 AM.
Additional Manufacturer Narrative · 1
A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION
Description of Event or Problem · 1
A PATIENT INCIDENT INVOLVING PATIENT HARM HAS BEEN ALLEGED. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 966780 | PATIENT INFORMATION CENTER IX | PATIENT INFORMATION CENTER IX | MHX | PHILIPS NORTH AMERICA LLC | 866389 | 00884838093041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other |