N
Patient 1
A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
MAUDE MDR 7961081
- MDR report key
- 7961081
- Report number
- 1218950-2018-08056
- Event key
- 0
- Event type
- 3
- Date received
- 2018-10-12
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 401
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. BETTY HARRIS
- Address
- 3000 MINUTEMAN ROAD ANDOVER MA 01810 US
- Phone
- 978-978-9786
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MP5 | PATIENT MONITOR | PHILIPS MEDICAL SYSTEMS | BZQ | M8105A (865024) | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-10-12 | 0 | 1. R |
Event Narratives#
D
Patient 1
THE CUSTOMER REQUESTED TO HAVE THE PIC LOGS READ SINCE A PATIENT CODED AND WAS DISCHARGED WITHOUT SAVING BECAUSE THEY WANTED TO REVIEW THE ALARM DATA. IT IS NOT CLEAR IF USE OF THE DEVICE MAY HAVE BEEN A FACTOR IN THE EVENT. THE PATIENT CODED.
N
Patient 1
THE CUSTOMER REQUESTED TO HAVE THE LOGS READ SINCE A PATIENT CODED AND WAS DISCHARGED WITHOUT SAVING BECAUSE THEY WANTED TO REVIEW THE ALARM DATA. THE FIELD SERVICE ENGINEER WENT FOR ONSITE SERVICE AND PULLED LOGS FROM MP5, CENTRAL STATIONS. HE FORWARDED THE LOG FILES TO THE NATIONAL SUPPORT SPECIALIST TEAM (NSS) TO SEE IF DATA CAN BE PULLED FROM EITHER OF THE UNITS. THE PATIENT WAS DISCHARGED WITHOUT SAVING DATA. THE NSS STATED THAT NO DATA FOR THIS PATIENTS WAS STORED IN THE LOG FILES. NO FURTHER INVESTIGATION IS POSSIBLE. PATIENT DETAILS WERE NOT PROVIDED BY THE CUSTOMER. INSUFFICIENT INFORMATION WAS PROVIDED IN ORDER TO DETERMINE IF ALARM RECORDINGS WERE PROVIDED AT THE TIME OF A PATIENT INCIDENT. THE CUSTOMER REPORTED THAT A PATIENT CODED THE CUSTOMER BIOMED STATED THAT THEY JUST WANTED TO GO OVER THE ALARM DATA. THEY DISCHARGED THE CENTRAL STATION SECTOR AND MONITOR BEFORE OBTAINING ANY REVIEW DATA. THEY ARE NOT CLAIMING MONITORING HAD A ROLE IN THE CODE. DUE TO THE LACK OF THE AVAILABLE INFORMATION A MALFUNCTION OF THE DEVICE CAN NOT BE RULED OUT. NO PARTS WERE REPLACED. THE DEVICE REMAINS AT THE CUSTOMER SITE.