MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2012-07-09 for ECG EVENT RECORDER CCST80X4 manufactured by Spacelabs Healthcare Ltd..
[2873489]
Spacelabs received a report that a cardiocall ecg event recorder was hot and melted the plastic enclosure close to the battery. A patient stated that he was burned.
Patient Sequence No: 1, Text Type: D, B5
[10066748]
Spacelabs is filing this report because we were advised a patient injury involved in this complaint on (b)(6) 2012. The initial complaint received on (b)(4) 2011 did not identify any patient involvement therefore no mdr was filed. The subject device was returned to spacelabs facility for investigation. The root cause was identified as battery short, which was caused by an improperly trimmed wire on the negative contact piercing insulation on the battery and shorting to the positive side of battery. Spacelabs requires wires be trimmed flush after soldering in the assembly procedures. Spacelabs has updated the assembly process work instruction by adding photos to clearly indicate correct trimming of wire after soldering to battery contact. Retraining of this process was conducted to prevent any future reoccurrences. The customer's unit has been replaced. A review of available data did not identify any similar complaints. We consider this malfunction to be an isolated case. We have concluded that no further action is required and consider this issue closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3023361-2012-00032 |
| MDR Report Key | 2646385 |
| Report Source | 01,07,08 |
| Date Received | 2012-07-09 |
| Date of Report | 2012-07-09 |
| Date of Event | 2011-09-28 |
| Date Mfgr Received | 2012-06-22 |
| Device Manufacturer Date | 2010-10-12 |
| Date Added to Maude | 2012-10-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. MIAOMIAO ZHENG |
| Manufacturer Street | 5150 220TH AVE SE |
| Manufacturer City | ISSAQUAH WA 98029 |
| Manufacturer Country | US |
| Manufacturer Postal | 98029 |
| Manufacturer Phone | 4256577200 |
| Manufacturer G1 | SPACELABS MEDICAL INC. |
| Manufacturer Street | 5150 220TH AVE SE |
| Manufacturer City | ISSAQUAH WA 98029 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98029 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECG EVENT RECORDER |
| Generic Name | CARDIOCALL |
| Product Code | DXH |
| Date Received | 2012-07-09 |
| Returned To Mfg | 2011-10-14 |
| Model Number | CCST80X4 |
| Device Expiration Date | 2011-10-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPACELABS HEALTHCARE LTD. |
| Manufacturer Address | 1 HARFORDE COURT JOHN TATE ROAD HERTFORD, SG137NW UK SG13 7NW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-09 |