MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL; ZOLL R SERIES ALS

Model Number R SERIES

Device Problems Loose or Intermittent Connection (1371); Unexpected Shutdown (4019)

Patient Problems Bradycardia (1751); Death (1802)

Event Date 07/11/2019

Event Type  Death  

Event Description

Pt experienced pea and was successfully resuscitated after acls lasting 21 mins.Zoll pads were placed on the pt.Rosc was achieved, but pt was bradycardic.External pacing was begun with the zoll unit.Pacing rate of 60 bpm with output of 60ma was capturing and confirmed with a pulse check.One hour and fifty eight mins after the pacing had started, the pt heart rate was observed to be dropping in the fifties and the zoll unit was observed to be off with no lights or pacing.The staff called a code and began acls for pea.It was confirmed that the unit was plugged in.The unit was unplugged and plugged into a different outlet.The unit came on and then immediately cycled off.A different zoll unit was obtained and it was discovered that the pigtail plug from the original unit was loose from the wall cord.The second zoll unit functioned properly.Rosc was achieved after eight mins.The pt was bradycardic and a pacing rate of 60 bpm with output of 70ma initiated.Clinical engineering interrogated the unit, and all checks were within normal operating parameters.It was determined that if the unit had been plugged in, but the connecting cord was loose, then the unit was operating on battery power and eventually turned off after battery power was drained.There is no mechanism to hold the two cords together, and the cord can become loose or unplugged.The audible alarm for low battery cannot be heard over the pacing tone, and per the nursing staff, only alarms once prior to battery depletion.

• Brand Name: ZOLL
• Type of Device: ZOLL R SERIES ALS
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill rd; chelmsford MA 01824
• MDR Report Key: 8842501
• MDR Text Key: 152783876
• Report Number: 8842501
• Device Sequence Number: 1
• Product Code: DRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: R SERIES
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/23/2019
• Distributor Facility Aware Date: 07/11/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 98