MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-01-04 for MAC 5500 manufactured by Wipro Ge Healthcare Private Ltd..
[1814892]
Per (b)(4): "volun (b)(6)-2010: the electrocardiogram diagnosis computer interpreted an electrocardiogram as "sinus tachycardia with premature atrial complexes", when the rhythm was actually atrial tachycardia with two to one block. The treatments and morbidity of these two rhythm entities are different. Often, the over reading doctor does not alter the interpretation of the electrocardiogram device, allowing the pt to be carried and treated for an incorrect diagnosis. "
Patient Sequence No: 1, Text Type: D, B5
[8927116]
Report (b)(4) was sent to ge healthcare via the medwatch program. Customer info and the device serial number involved were not provided. Ge healthcare contacted fda regarding the referenced report and was informed that the customer will not release any additional info to the manufacturer. While there was no confirmed injury identified, the medwatch report sent by the user facility indicated the event report type as "injury. " the reported event cannot be investigated with the info available at this time. If additional info is received, a follow up report will be submitted. Product labeling states that all electrocardiograms must be overread by a cardiologist or qualified physician. Reference the attached pages from the 12sl physician's guide and mac 5500 operator's manual. Similar warnings are present in the operator's manual for every product that contains the 12sl ecg analysis program.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617277-2011-00001 |
| MDR Report Key | 1959723 |
| Report Source | 00 |
| Date Received | 2011-01-04 |
| Date of Report | 2011-01-04 |
| Date of Event | 2010-10-18 |
| Date Mfgr Received | 2010-12-06 |
| Date Added to Maude | 2011-01-18 |
| 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 5500 |
| Generic Name | ELECTROCARDIOGRAPH |
| Product Code | LOS |
| Date Received | 2011-01-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2011-01-04 |