MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS CBL 5 LEAD SET SNAP IEC, ICU; ECG LEAD SET

Model Number	989803145001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Serial number not provided.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
The customer stated that the mrx is failing operational checks during the "leads ecg check".The device was not in use and there was no reported patient/user impact.
Additional Manufacturer Narrative
Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
Event or Problem Description
The customer stated that the mrx is failing operational checks during the "leads ecg check".The device was in use and there was no reported patient/user impact.
Additional Manufacturer Narrative
Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: CBL 5 LEAD SET SNAP IEC, ICU
• Common Device Name: ECG LEAD SET
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 8429633
• Report Number: 9610816-2019-00077
• Device Sequence Number: 19281416
• Product Code: MHX
• UDI-Device Identifier: 00884838010833
• UDI-Public: (01)00884838010833
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K062283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 989803145001
• Device Catalogue Number: 989803145001
• Device Lot Number: 2018-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 03/12/2019; 03/12/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 03/26/2019; 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1