MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-11-17 for MAC 1200 manufactured by Wipro Ge Healthcare Private Ltd.
[15211311]
A site initially reported to ge healthcare on (b)(6) 2008 that a nurse felt a tingling sensation on her fingertips from typing in pt info while performing an ekg (electrocardiograph) on a pt. The nurse's finger tips reportedly turned white on the surface, however no serious injury was reported at this time. On (b)(6) 2010, the site informed ge that the nurse involved in the reported event had sustained second degree burns on the wrist and hand. The nurse was evaluated by a physician and was treated with bacitracin and bandages. The nurse was reportedly able to return to work the same day of the event.
Patient Sequence No: 1, Text Type: D, B5
[15730138]
The mfg site received the unit for investigation. The keypad was viewed under a 40x microscope to observe any puncture in the keypad. No abnormality was observed. The unit also underwent safety tests confirming that the unit's leakage current was within specification. The unit was then tested while switched off and while switched on, both on mains and battery power. No failures were observed. The reported issue could not be replicated. Based on the results of the investigation, and due to the construction of the keypad, low voltage and minimal current of the device, it is unlikely that the unit's keypad contributed to the pt burn. The root cause of the reported event could not be determined. As a preventive measure, the unit was replaced at the customer site.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617277-2010-00004 |
| MDR Report Key | 1908033 |
| Report Source | 06 |
| Date Received | 2010-11-17 |
| Date of Report | 2010-11-17 |
| Date of Event | 2008-12-03 |
| Date Mfgr Received | 2010-10-21 |
| Device Manufacturer Date | 2008-07-01 |
| Date Added to Maude | 2010-12-01 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GWEN BRAEGER |
| Manufacturer Street | 3000 N GRANDVIEW BLVD MAIL CODE - W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482608 |
| Manufacturer G1 | WIPRO GE HEALTHCARE PRIVATE LTD |
| Manufacturer City | BANGALORE |
| Manufacturer Country | IN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAC 1200 |
| Generic Name | ELECTROCARDIOGRAPH |
| Product Code | LOS |
| Date Received | 2010-11-17 |
| Returned To Mfg | 2009-02-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WIPRO GE HEALTHCARE PRIVATE LTD |
| Manufacturer Address | BANGALORE IN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-11-17 |