MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION ZOLL CARDIAC MONITOR; MOBILE CARDIAC TELEMETRY MONITOR

Model Number ZOLL CARDIAC MONITOR

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Irregular Pulse (2469)

Event Date 09/23/2023

Event Type  Injury  

Manufacturer Narrative

A repackaging/relabeling mix-up contributed to this event where the serial number printed on the shipping box did not match the serial number of the device inside the shipping box.Patient was expected to receive serial number (b)(6) and received serial number (b)(6).

Event Description

A patient, undergoing cardiac monitoring using a zoll mobile cardiac monitor, received a pacemaker that may not have been appropriate based on the correct monitoring data.

• Brand Name: ZOLL CARDIAC MONITOR
• Type of Device: MOBILE CARDIAC TELEMETRY MONITOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA
• Manufacturer Contact: zoll mfg corporation ; 121 gamma drive; pittsburgh, PA 15238
• MDR Report Key: 18180901
• MDR Text Key: 328619758
• Report Number: 3008642652-2023-11834
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ZOLL CARDIAC MONITOR
• Date Manufacturer Received: 11/08/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female