MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-10-12 for MP5 M8105A (865024) manufactured by Philips Medical Systems.
[123572666]
A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[123572667]
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.
Patient Sequence No: 1, Text Type: D, B5
[183187735]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2018-08056 |
| MDR Report Key | 7961081 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-12 |
| Date of Report | 2018-09-14 |
| Date Mfgr Received | 2018-09-14 |
| Device Manufacturer Date | 2013-04-16 |
| Date Added to Maude | 2018-10-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. BETTY HARRIS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MP5 |
| Generic Name | PATIENT MONITOR |
| Product Code | BZQ |
| Date Received | 2018-10-12 |
| Model Number | M8105A (865024) |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-12 |