MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problems Device Inoperable (1663); Device Operational Issue (2914)

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

Event Date 01/09/2017

Event Type  malfunction  

Manufacturer Narrative

The reported event was confirmed based on the functional testing of the autopulse platform (sn (b)(4)) and the root cause is due to a defective power switch cable.It was observed that the platform does not power on during initial functional testing.It was identified that the power switch cable was defective and had to be replaced.Upon replacement with a test power switch cable, the platform was subjected to further functional testing and passed.The platform operated for 10 minutes with continuous compression using a light resuscitation test fixture without any observed errors.No visual damage was observed during visual inspection of the platform and the review of the retrieved archive data did not any show errors.Device history record (dhr) was reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).The autopulse platform is a reusable device and was manufactured on 29 apr 2016.The death was not related to the use of the autopulse device.The autopulse is intended to be used as an adjunct to manual cpr on adult patients.If the autopulse did not compress or stopped compression, manual cpr should be performed as standard of care.In this case, autopulse did not provide compression and was not used.Manual cpr was performed.Autopulse did not cause or contribute to the patient's death.

Event Description

It was reported that the autopulse platform (sn (b)(4)) did not power on during a patient call and exchanging to another battery did not resolve the issue.Following the observed event, a manual cpr was then performed; however, a return of spontaneous circulation was not achieved.Multiple attempts were made to obtain additional information but have been unsuccessful.It was further reported that once the customer got back to the station, the platform was tested with a newly charged battery and the platform was able to power on.The next day, during routine check, a recurrence of the platform not powering on was observed.It was noted that the platform was tested with two newly charged batteries and the batteries were able to power the customer's other platforms.No further information was provided.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 6300799
• MDR Text Key: 66503486
• Report Number: 3010617000-2017-00063
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2016
• 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