MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-18 for HALL LITHIUM BATTERY CHARGER L3000 manufactured by Consolidated Medical Equipment.
[179920879]
At time of filing, although expected, the reported device has not been returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[179920880]
On behalf of the customer, the conmed sales representative submitted photos and reported an issue involving the l3000, lithium battery charger sn (b)(4) that occurred at (b)(6) hospital. It was noted when charging a battery l3000lg on (b)(6) 2020 the charger caught on fire. There were no outside sources that could have caused the fire. Information from the facility indicates that no one was injured, there was no patient or surgical involvement. The charger and battery were located within the central sterile processing room. Only one of the four connection points was involved with the fire. The battery had not been on the charger any longer than 2-3 hours as they rotate the batteries frequently during use. It was stated the charger is kept in use throughout the day, and as they process batteries through the cycles they will rotate the batteries onto the charger. As per witnesses, the flames originated from inside of the charger, and stemmed upwards through the battery which then caused the melting of the battery and surrounding area on the charger itself. There were flames also coming from the charging station slot #1 where the battery was connected. The staff utilized a fire extinguisher to put out the flames. The other charging stations had been in use when the accident occurred but there was no evident or visible damage to the other batteries on the charging station. Those other batteries were separated from the rotation and were sent out with the other pieces of equipment as precaution. There were no visible damages to the cord before or after the fire, but it was sent out for evaluation as well. This report is being raised on the basis of malfunction with potential for injury upon reoccurrence due to fire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2020-00072 |
| MDR Report Key | 9722659 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2014-01-28 |
| Date Added to Maude | 2020-02-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS TRACEY WEISELBENTON |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO, FL |
| Manufacturer Country | US |
| Manufacturer Phone | 3995557 |
| Manufacturer G1 | CONSOLIDATED MEDICAL EQUIPMENT |
| Manufacturer Street | ALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA |
| Manufacturer City | CHIHUAHUA, MEXICO 31136 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 31136 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HALL LITHIUM BATTERY CHARGER |
| Generic Name | BATTERY, REPLACEMENT, RECHARGEABLE |
| Product Code | MOQ |
| Date Received | 2020-02-18 |
| Returned To Mfg | 2020-02-12 |
| Catalog Number | L3000 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONSOLIDATED MEDICAL EQUIPMENT |
| Manufacturer Address | ALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA CHIHUAHUA, MEXICO 31136 MX 31136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-18 |