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

Model Number MODEL 100

Device Problem Device Issue (2379)

Patient Problem Laceration(s) (1946)

Event Date 12/29/2016

Event Type  Injury  

Manufacturer Narrative

The autopulse platform (s/n: 41309) is expected to be returned to zoll for investigation; however, the device has not yet been received.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

Per the customer, a (b)(6) male presented with chest pain at the accident & emergency (a&e) department.The patient was taken into the resuscitation area and soon after had a cardiac arrest.A unknown amount of cpr, medicine administration, and defibrillation were performed.The autopulse was deployed approximately 20 minutes later.According to the emergency department's (ed) clinical educator, the lifeband (in retrospect) seemed to be positioned a bit high on the patient.At one point, the patient experienced a return of spontaneous circulation (rosc) and the platform was powered off.The patient later required use of autopulse again.Per ed clinical educator, the lifeband appeared to have re-positioned itself appropriately and patient was transferred to cath lab with autopulse in situ and active.There was lateral transfer to the cath lab table with continued use of autopulse and according to the ed clinical educator, the lifeband position was not checked after transfer.During the patient's time in the cath lab, it is not specified when the autopulse platform was used and later powered off.Upon leaving the cath lab, the patient reportedly became haemodynamically unstable and their blood pressure dropped.More fluids were administered.This reportedly occurred as a result of the vasodilator effects of medications that were administered.The attending cardiologist reported possible bleeding from one of the access sites or retroperitoneal bleeding and requested that it be monitored.The patient expired an unspecified time later.Multiple requests were made by zoll for the autopsy report.To date, zoll has not received a copy of the autopsy findings.The onsite cardiologist indicated that the patient suffered a cpr injury and that it was his opinion that the autopulse was the cause of this patient's death.The customer reports that the onsite cardiologist was not present at the time of the events, but rather reviewed data that was provided by the attending health care team.

Manufacturer Narrative

Device history record (dhr) was reviewed for service information related to the reported complaint and there was no previous history of reported complaints for the autopulse (s/n: (b)(4)).Visual inspection was performed on the returned autopulse platform.No physical damage was observed but we found traces of blood ingress inside.During the functional test, the encoder drive shaft was found to not rotate smoothly.However, the platform passed the initial functional testing without error messages.The load cells and other functional parameters of the autopulse were all within our specifications.The returned lifeband (lot# 160205) was visually inspected, no physical damage was found.Multiple run-in tests were performed using the returned lifeband on a 95% patient large resuscitation test fixture.No user advisories or errors were observed during the run-in tests.Review of the archive data revealed that on the presumed event date ((b)(6) 2016), a properly charged battery (s/n: (b)(4)) was installed in the platform.The user advisory 2 (ua2) occurred after 25 compressions and cleared.The ua2 is an indication that the patient may not have been aligned properly on the platform or the lifeband is open.Once the ua 2 was cleared, the autopulse performed 539 compressions (for approximately 7 minutes) on a stiff patient as indicated by the archive value of (b)(6) of load.After 539 compressions, the autopulse was manually stopped for unknown reason.Following which autopulse performed 7 compressions and stopped with ua 17.Ua 17 can occur when the compression depth cannot be reached in time possibly due to low battery, a twisted lifeband and or the stiffness of the patient.The ua 17 was cleared and the autopulse was manually stopped 3 times in rapid succession after few compressions each time.After the third manual stop, ua 45 was encountered, which indicates that the lifeband straps were not pulled completely out prior to turning on the device.The ua 45 was cleared and device performed compressions for 10 minutes.It was noticeable that the device was manually stopped 12 times in this 10 minutes for the reasons not stated by the user.Conclusion: based on the investigation, we conclude that the autopulse performed as intended on the incident date and met all specifications during our investigation.All the user advisories raised by the autopulse are as intended for patient safety and best possible cpr.None of them indicate malfunction of the device.Ua 2 and ua 45 reflect a user error.Ua 17 is an indicator of excessive stiffness of the patient's chest.Zoll is unable to explain the rationale behind the large number of manual stops (i.E., turning off the autopulse) during compressions cycles that were running normally.There are no indications of a autopulse malfunction.

Event Description

On 03 january 2017, the zoll representative met with the customer to review the use of the autopulse platform in relation to reported event.The onsite cardiologist indicated that the patient suffered a compression injury as there was evidence of cutaneous abrasion on the chest.Anticoagulation was administered as a pre-requisite of coronary intervention.It was reported that bleeding was the cause of death in this patient.It was noted that the patient's hemoglobin dropped from 120 to 30 g/l.General surgery did not take the patient for laparotomy due to a recent mi.No further information was provided to zoll for bleeding location or cause.

• 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: 6284911
• MDR Text Key: 65998771
• Report Number: 3010617000-2017-00069
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000079
• UDI-Public: 00849111000079
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• 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: 8700-0700-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2015
• 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 Age: 65 YR