MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-31 for TOTE-L-VAC AI4900000 manufactured by Ohio Medical.
[47299134]
Device will be evaluated upon return.
Patient Sequence No: 1, Text Type: N, H10
[47299135]
Battery warped/ damaged. Per our customer report "i just called the customer and asked what they were doing when this occurred. He stated they just got back from a call. He went in to do his report. When he got done, he went to the unit to start his equipment check. When he opened the door to get in, all he could smell was the sulfur smell of burning battery. They checked around and narrowed down where it was coming from and they found the battery that way. They did not use the suction unit on the call. "
Patient Sequence No: 1, Text Type: D, B5
[49180044]
Battery manufacturer provided the following: "this is not an exploded battery. There appears to be no disruption to the case integrity from photos shown. It is swollen, this is known as thermal run away. Typically this swelling occurs when charging a battery that has been over discharged and/ or past end of life. It can also occur if charging is dont above the rated charging temperature". Device was returned and new battery was placed in unit. Battery was charged for >5 days and original occurrence described by customer could not be duplicated. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[49180105]
Battery manufacturer provided the following: "this is not an exploded battery. There appears to be no disruption to the case integrity from photos shown. It is swollen, this is known as thermal run away. Typically this swelling occurs when charging a battery that has been over discharged and/ or past end of life. It can also occur if charging is dont above the rated charging temperature". Device was returned and new battery was placed in unit. Battery was charged for >5 days and original occurrence described by customer could not be duplicated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419185-2016-00027 |
| MDR Report Key | 5689895 |
| Date Received | 2016-05-31 |
| Date of Report | 2016-06-30 |
| Date of Event | 2016-03-30 |
| Date Mfgr Received | 2016-04-14 |
| Device Manufacturer Date | 2001-08-21 |
| Date Added to Maude | 2016-05-31 |
| 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 | MS JESSICA BARRILE |
| Manufacturer Street | 1111 LAKESIDE DR |
| Manufacturer City | GURNEE IL 60031 |
| Manufacturer Country | US |
| Manufacturer Postal | 60031 |
| Manufacturer Phone | 8478556318 |
| Manufacturer G1 | OHIO MEDICAL LLC |
| Manufacturer Street | 1111 LAKESIDE DR |
| Manufacturer City | GURNEE IL 60031 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOTE-L-VAC |
| Generic Name | TOTE-L-VAC |
| Product Code | BTA |
| Date Received | 2016-05-31 |
| Returned To Mfg | 2016-06-08 |
| Model Number | AI4900000 |
| Catalog Number | AI4900000 |
| Lot Number | TLV011014 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO MEDICAL |
| Manufacturer Address | 1111 LAKESIDE DR GURNEE IL 60031 US 60031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-31 |