MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-04-02 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004021 manufactured by Independence Technology, L.l.c..
[15683364]
User reported that the upper portion of the center post of the battery charger port on the main chassis was blackened, which the user likened to an electrical short circuit. The user had not noticed this previously. When consulted by the service center, 2nd level engineering support indicated that this might be the reason for the reported difficulty in charging the device batteries and battery charger operation reported by the user. No allegation of fire, smoke, smell or other unusual phenomena or problem was observed or reported by the user. This event was not accompanied by any allegation of injury or harm to the user or others. The user's main chassis and battery charger were replaced and returned to the manufacturing location for further evaluation.
Patient Sequence No: 1, Text Type: D, B5
[15849151]
Service was dispatched to replace the device main chassis and exchange the user's battery charger. A report on field service activity (sar) and a device checkout record (fcr) were forwarded to the complaint handling unit (chu) per standard operating procedure. The user has not reported any recurrence of the described event since the completion of the device activity. The main chassis and battery charger were evaluated once returned to the mfr location to confirm or refute the reported issue. The main chassis evaluation confirmed the dark spot reported by the user, however, the assembly was fully functional in accordance with all current specifications. When the battery charger was initially evaluated by connecting it to a known good sample device, the reported issue was confirmed. A detailed evaluation summary is attached to this report. It has been determined that this same event has occurred with this user on two (2) separate occasions, with 2 different battery chargers. This event has not been observed or reported by another user, nor has it been observed throughout product development or with any company product consultant or clinician. Based on the results of this evaluation, and known usage patterns of the user, the company will monitor the use and environment of this charger by this user prior to further action being taken. The battery charger was returned used. There is a blackened portion of the connector cable at the base of pins 1 and 2. The connector cable's plastic shield and pins are intact. The battery charger was connected to the sample chair. The battery charger indicated yellow led's for approx 60 seconds and then switched to a red default led on the left (a side). The battery charger was powered off. The charger was extremely difficult to disengage from the sample device. Once disengaged, it was apparent that the battery charger connector cable had blackened the charger port on the sample device in an identical fashion to the main chassis returned from the consumer's device in this incident. The two female connector pins 1 and 2 of the sample device had been blackened and overheated, causing further physical damage. The charger connector cable emitted a burned plastic color. A sample of 25 returned main chassis was inspected for damage similar to the damage caused by the faulty charger. No damage was detected on any of the field-returned main chassis inventory. Additionally, cts refurbishment activities have not detected a blackened charger port on a field-returned main chassis similar to the one caused by the faulty charger on the 175+ units refurbished. The battery charger was forwarded to cts electrical engineering for further investigation. Cts electrical engineering isolated the cause of the short to the connector cable of the charger. The connector cable was severed from the cable housing at a point just beyond the plastic shield. Cts engineering results are as follows: unusually low impedances were seen between pins 1 (htsv) and 2 (+batt a charge) of the output connector of battery charger. Eventually the output connector was cut off its output cable and showed an 8 ohm impedance between pins 1 and 2. Impedances between all other pins were the expected infinite. No physical damage or marks could be seen on the plastic connectors housing. The low connector impedances seen between adjacent pins in both these charges would support the functionality seen in the field. Field-returned chargers from previous complaints on this vin were available to test the cable connector in the same fashion as this recent return. The results of the add'l investigation on the connector of that charger are as follows: battery charger returned on 01/30/2007. Unusually low impedances were seen among pins 1 (htsv), 2 (+batt a charge), and 13 (+batt b charge) of the output connector of battery charger. Eventually the output connector was cut off its output cable and showed an 132 ohm impedance between pins 1 and 2 and 10 ohm impedance between 1 and 13, impedance between all other pins were the expected infinite. No physical damage or marks could be seen on the plastic connectors housing. Battery charger returned on 02/28/2007. The charger connector cable was blackened at the base of pin 1 and 2 in an identical fashion to s/n 746 of this incident. Deka reports there are no impedances between pins 1 and 2 or 13. A test of the sample charger used in this investigation to test the batteries and main chassis indicated no impedances. The reported concern of the blackened port on the main chassis was confirmed as in this report. The blackened condition could be reproduced at cts with the consumer's returned charger. The battery charger does not meet final acceptance specifications due to the short in the battery charger caused by the faulty connector. The part evaluation is submitted to the chu for review.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2007-00003 |
| MDR Report Key | 886292 |
| Report Source | 04 |
| Date Received | 2007-04-02 |
| Date of Report | 2007-03-30 |
| Date of Event | 2007-03-07 |
| Date Mfgr Received | 2007-03-07 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2007-07-30 |
| 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 | 0 |
| Manufacturer Contact | MICHAEL O'MEARA, DIRECTOR |
| Manufacturer Street | 45 TECHNOLOGY DRIVE |
| Manufacturer City | WARREN NJ 07059 |
| Manufacturer Country | US |
| Manufacturer Postal | 07059 |
| Manufacturer Phone | 9084122200 |
| Manufacturer G1 | CREATIVE TECHNOLOGY SERVICES |
| Manufacturer Street | 7444 HAGGERTY ROAD |
| Manufacturer City | CANTON MI 48187 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 48187 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDEPENDENCE IBOT 4000 MOBILITY SYSTEM |
| Generic Name | STAIR CLIMBING WHEELCHAIR |
| Product Code | IMK |
| Date Received | 2007-04-02 |
| Returned To Mfg | 2007-03-21 |
| Model Number | NA |
| Catalog Number | IT004021 |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 863992 |
| Manufacturer | INDEPENDENCE TECHNOLOGY, L.L.C. |
| Manufacturer Address | 45 TECHNOLOGY DR. WARREN NJ 07059 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-04-02 |