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

Model Number M1604A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

The customer stated that the mrx is failing operational checks during the "leads ecg".There was no reported patient incident injury.

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 Description

The customer stated that the mrx is failing operational checks during the "leads ecg".The device was in use.There was no reported patient incident injury.

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 SNAP CHEST IEC, ICU
• Type of Device: CBL 5 LEAD SNAP CHEST IEC,ICU
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 8451175
• MDR Text Key: 139986403
• Report Number: 9610816-2019-00078
• Device Sequence Number: 1
• Product Code: DSA
• UDI-Device Identifier: 00884838010581
• UDI-Public: (01)00884838010581
• Combination Product (y/n): N
• PMA/PMN Number: K020531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: M1604A
• Device Catalogue Number: 989803144921
• Device Lot Number: 2018-09X5 2018-10X2
• 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 Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 03/12/2019; 03/12/2019
• Supplement Dates FDA Received: 03/27/2019; 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1