MAUDE Adverse Event Report: REMINGTON MEDICAL REMINGTON MEDIAL

Model Number ADAP-2000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiopulmonary Arrest (1765); Complete Heart Block (2627)

Event Type  malfunction  

Manufacturer Narrative

A review of this dhr for this lot of product identified no issues with the product quality.All product was 100% inspected for functionality.Based on the information provided from the customer that both the temporary pacemaker and cable were replaced and were then able to pace, therefore it can not be determined if the cable or the temporary pacemaker was defective.The remaining cables from the lot (1903615) have been requested for return form the customer to complete the investigation.

Event Description

The following was reported to remington medical on (b)(6) 2019: while preparing to place a permanent pacemaker we [device user] was placing the temporary pacemaker to use as backup during the procedure.As we [device user] were preparing to place the temporary pacemaker the patient went into asystole and then 3 deg heart block.The temp pace was placed but did not work.A code blue was called and the patient had chest compressions and was intubated.Another temporary pacemaker and cables was opened and placed and was able to pace.

Manufacturer Narrative

A review of this dhr for this lot of product identified no issues with the product quality.All product was 100% inspected for functionality.Based on the information provided from the customer that both the temporary pacemaker and cable were replaced and were then able to pace, therefore it can not be determined if the cable or the temporary pacemaker was defective, the remaining cables from the lot (1903615) have been requested for return form the customer to complete the investigation.10/15/2019: follow-up u.Based on the inspection/testing results from the investigation the complaint was confirmed but the cause was not due to a failure of the remington adap 2000 cable.

Event Description

The following was reported to remington medical on 7/31/2019: while preparing to place a permanent pacemaker we [device user] was placing the temporary pacemaker to use as backup during the procedure.As we [device user] were preparing to place the temporary pacemaker the patient went into asystole and then 3 deg heart block.The temp pace was placed but a code blue was called and the patient had chest compressions and was intubated.Another temporary pacemaker and cables was opened and placed and was able to pace.

• Brand Name: REMINGTON MEDIAL
• Type of Device: REMINGTON MEDIAL
• Manufacturer (Section D): REMINGTON MEDICAL; 6830 meadowridge court; alpharetta GA 30005
• MDR Report Key: 9255774
• MDR Text Key: 217161504
• Report Number: 1056553-2019-00001
• Device Sequence Number: 1
• Product Code: DSA
• UDI-Device Identifier: 00813079021230
• UDI-Public: (01)00813079021230(10)1903615(17)220205(01)0
• Combination Product (y/n): N
• PMA/PMN Number: K971968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

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 Expiration Date: 02/05/2022
• Device Model Number: ADAP-2000
• Device Catalogue Number: N/A
• Device Lot Number: 1903615
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/30/2019
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: 07/30/2019
• Supplement Dates FDA Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention