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 2018-04-05 for BIS 186-1046 manufactured by Aspect Medical.
[104536402]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[104536403]
According to the reporter, there was a lot of smoke coming out of the back of the monitor immediately after the anesthesia machine was unplugged from the wall. There was no flame reported and there was no reported power surge at that time. It was indicated that there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[117310719]
Additional info: udi#. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[131526147]
Evaluation summary one product was received for analysis. The technical root cause of the reported issue was an internal short due to the failure of the insulation layer within the electrodes of the battery cell due to the age of the battery cell. The preventative maintenance specified in the user manual is unclear and ineffective in preventing batteries of advanced age from existing within the installed base. The systemic root cause was due to a failure to systematically review the design of the implementation of lithium battery design and maintenance after the acquisition of this monitor through the purchase of aspect medical by covidien. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2018-00233 |
| MDR Report Key | 7400254 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-05 |
| Date of Report | 2018-11-14 |
| Date of Event | 2018-03-07 |
| Date Mfgr Received | 2018-10-25 |
| Date Added to Maude | 2018-04-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AVI KLUGER |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | ASPECT MEDICAL |
| Manufacturer Street | 1 UPLAND RD |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02062 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIS |
| Product Code | OLW |
| Date Received | 2018-04-05 |
| Returned To Mfg | 2018-03-22 |
| Model Number | 186-1046 |
| Catalog Number | 186-1046 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPECT MEDICAL |
| Manufacturer Address | 1 UPLAND RD NORWOOD MA 02062 US 02062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-05 |