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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the zoll platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

As reported during use on the (b)(6) years old male patient that weighed approximately (b)(6) pounds, the autopulse platform ((b)(4)) displayed error message user advisory (ua) 07 (discrepancy between load 1 and load 2), after performing 10 compressions.The patient was re-positioned and the platform was rebooted, however, the customer was not able to clear the error message.The use of the autopulse was discontinued and manual cpr was performed for 25 minutes during the transport.No known impact or patient consequence was reported.

Manufacturer Narrative

The customer's reported complaint of autopulse platform sn (b)(4) platform stopped compressions and displayed user advisory (ua) 07 (discrepancy between load 1 and load 2) error message was confirmed during archive review but not during functional testing.There were no device deficiencies found during evaluation of the returned platform that could have caused or contributed to the reported complaint.Visual inspection of the returned platform was performed and found no physical damage.Review of the archive data indicated error message user advisory (ua) 07 on the customer reported event date.Advisory (ua) 07 error message alerts the operator that the load sensing system has detected a weight/load imbalance between the two load cells.(ua) 07 indicated that either the patient not oriented on the autopulse platform correctly or the patient has shifted during compression.Load cell characterization test was performed and it indicated that both of the load cells are within specifications.The platform was also tested using the 95% patient test fixture large resuscitation test fixture (lrtf) with a good known test battery until discharged without any fault or error.The autopulse passed all the testing without any issue.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints reported for autopulse with serial number (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8220216
• MDR Text Key: 132392821
• Report Number: 3010617000-2019-00012
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• 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: 01/04/2019
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 91